Safety Scientist Resume Samples
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Safety Scientist Resume Samples
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EG
E Greenholt
Edmond
Greenholt
578 Krajcik Pine
Los Angeles
CA
+1 (555) 641 4837
578 Krajcik Pine
Los Angeles
CA
Phone
p
+1 (555) 641 4837
Experience
Experience
Detroit, MI
Drug Safety Scientist
Detroit, MI
Schroeder LLC
Detroit, MI
Drug Safety Scientist
- Provide medical operations expertise and help develop relevant training content for the case processing group and external vendors
- Ensure time management and assess quality of work
- Coordinate development of periodic safety reports and contribute to the development of aggregate reports as requested by US Drug Safety Medicine
- Work closely with Medical Directors and Associate Medical Directors to ensure alignment by providing operational expertise
- Alert Project Management when activities fall outside SOW
- Perform Sample QA per USDS and Serono guidelines in order to identify quality trends and implement preventative actions
- Perform initial assessment of non-adverse events to evaluate validity of report and identify requisite follow up
Chicago, IL
Clinical Safety Scientist
Chicago, IL
McLaughlin, Schuppe and Carter
Chicago, IL
Clinical Safety Scientist
- Provide input to improve process documents and SOPs and represents local perspective in procedure discussions
- Providing input into guidance documents and process improvement initiatives
- Contribute to the production of, and updates to, Risk Management Plans for CSL manufactured products, including drafting of the safety sections
- Performing reconciliation activities for clinical trial data
- Monitoring of FDA late reports and E2B failures via the Worklist in Argus
- Perform reconciliations of AE/pregnancy data
- Perform other duties as assigned
present
Philadelphia, PA
Senior Safety Scientist
Philadelphia, PA
Hermiston, Deckow and Doyle
present
Philadelphia, PA
Senior Safety Scientist
present
- Maintain oversight of case workflow; act as Workflow Manager for specific projects
- Collaborate with Management to update or design project process improvements
- Senior Safety Scientist may support SSL or be responsible for the development and/or the execution of RMP or REMS risk mitigation activities
- Alert Project Management when activities fall outside SOW or documented processes
- Assist in evaluation and validation of systems to support safety
- Assist in the reconciliation of clinical and safety databases
- Perform literature review for identification of case reports and other relevant safety information
Education
Education
Bachelor’s Degree in Accuracy
Bachelor’s Degree in Accuracy
Pepperdine University
Bachelor’s Degree in Accuracy
Skills
Skills
- Strong quality focus, with a good understanding of quality systems
- Strong relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting
- Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines
- Knowledge of the clinical areas for which Mallinckrodt markets products which include Contrast Media, as well as finished pharmaceutical dosage products
- Ability to multitask with exceptional time management skills
- Excellent communicator, both oral and written, specifically medical writing skills
- Ability to critically analyze individual and aggregate safety data with scientific rigor
- Knowledge in the review and analysis of the medical literature
- Demonstrable skills in reviewing and summarizing medical records
- Excellent written and verbal communication skills to a variety of levels and teams, internally and externally
15 Safety Scientist resume templates
Read our complete resume writing guides
1
Senior Safety Scientist Resume Examples & Samples
- A minimum of 3-5 years for the Senior Scientist, with experience in managing adverse events processing on a global basis
- The candidate should have knowledge of ICH/FDA guidelines for GCP and Clinical Safety Reporting on a global basis
- Experience with the use of global safety databases is required
2
Ubc-experienced Drug Safety Scientist Resume Examples & Samples
- Review project specific proposals, pricing and protocols to ensure consistency within the AERP Maintain a listing of all administrative changes and updates
- Alert Project Management when activities fall outside SOW
- Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment
- Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment
- Collaborate with Senior Management to update or design project process improvements
- Liaise with both internal and external vendors (clients, patients and HCPs)
- Review/Quality Check (QC) of source documents, coding, data entry, report generation and distribution
- Assist in evaluation and validation of systems to support safety
- Proficient with case review, extrapolation and composition of ICSR narratives and causality assessment
- Proficient with computer programs (Safety database, Word, PowerPoint, Excel)
- Fluent in English, additional language fluency a plus, but not required
- Ability to multitask with exceptional time management skills
- LI-KB1
3
Safety Scientist Resume Examples & Samples
- Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required
- Review project specific proposals, pricing and protocols to ensure consistency within the AERP
- Maintain a listing of all administrative changes and updates
- Ensure all processes’ as described are operational
- Participate in change order generation
- Actively engage in gap analysis for SOPs and guidance documents
- Preparation of training materials specific to safety, participate and/or lead training sessions
- Assist in the reconciliation of clinical and safety databases
- Other duties as assigned by management
- Registered Nurse, Pharmacist, or other degree in a science-related field
- Knowledge of ICH, EMA and FDA Regulations and Guidelines both clinical and post marketing
- Prior experience in CRO/Pharma/Biotech safety department minimum 3 years
- Knowledge of vaccine and medical device reporting requirements, a plus
- Knowledge of database management and use of coding dictionaries Good communication, interpersonal interaction, project management and organizational skills are essential
4
Associate Safety Scientist, Medical Analytics Resume Examples & Samples
- Responsible for pharmacovigilance activities on a product, including signal detection and evaluation (from PV database, clinical database, literature)
- Contributes to Pharmacovigilance and Risk Management planning for designated products by analyzing the risks, preparation of safety strategies and highlighting and tracking potential issues
- Supports the preparation and maintenance of safety sections of the Clinical Protocols, Clinical Study Reports as well as the Company Core Data Sheet and Risk Management Plan
- Contributes to safety activities between PST and internal and external partners, represents Safety (Medical Analytics) in teams
- MS in Science or related field
- Understanding of pharmaceutical medicine (including drug development process and post-approval environments)
- Basic Project Management skills and Microsoft WORD and EXCEL skills
5
Global Safety Scientist Resume Examples & Samples
- Directs the planning, preparation, writing and review of portions of aggregate reports
- Organize and direct liaison activities with affiliates and other internal Amgen partner regarding products
- Supports and provides oversight with regards to safety in clinical trials to
6
Assoc Dir Clinical Safety Scientist Resume Examples & Samples
- Possesses strong medical or TA and drug development knowledge
- 5 years of experience with an advanced degree; 7 years of experience with a Bachelor’s degree
- Bachelor’s degree at minimum required; PharmD, PhD or MSN or higher nursing degree preferred
7
Drug Safety Scientist Resume Examples & Samples
- Provide initial medical evaluation of adverse events on company investigational and marketed products by determining the seriousness, expectedness, and therefore reportability of adverse events in line with FDA and global regulatory guidelines
- Collect high quality medical follow-up information for serious cases
- Perform quality review of clinical trial cases and develop queries as appropriate
- Perform quality review of post-marketing serious adverse event reports as applicable
- Perform initial assessment of non-adverse events to evaluate validity of report and identify requisite follow up
- Log onto USDS phone line to receive incoming calls of potential adverse event reports and document information according to approved standards
- Determine reportability including assessment of labeling for clinical trial and post-marketing cases processed by Global Drug Safety and distributed to US Drug Safety for potential reporting
- Determine if adverse events should be reported to other manufacturers as required
- Coordinate development of periodic safety reports and contribute to the development of aggregate reports as requested by US Drug Safety Medicine
- Support Product Lead in signal detection activities as assigned
- Participate in the set-up and approval of local clinical trials by developing drug safety manuals and SAE reconciliation plans, and conducting CRF reviews, and collaborating with US Drug Safety Medicine and GDS for the development and execution of Clinical Development plan as needed
- Collaborate with GDS Staff to ensure a consistent global approach to safety by participating in meetings and implementing global standards within the department
- Work closely with Medical Directors and Associate Medical Directors to ensure alignment by providing operational expertise
- Represent USDS Operations with respect to the safety aspects of investigational and marketed products with external groups and on select cross-functional teams as appropriate
- Provide medical operations expertise and help develop relevant training content for the case processing group and external vendors
- Participate in internal and external training programs, meetings, and conferences to continually improve and build a knowledge base of product safety and risk management
- Perform Sample QA per USDS and Serono guidelines in order to identify quality trends and implement preventative actions
- Obtain detailed knowledge of FDA and global safety regulations as applicable to assigned products and responsibilities
- Minimum of 2 years of drug safety experience required
- Project Management Skills
- Ability to work in intense, fast paced, matrixed, multinational work environment
- Ability to effectively communicate with employees, colleagues, and global counterparts
- Positive motivator
8
Drug Safety Scientist Resume Examples & Samples
- Knowledge of the clinical areas for which Mallinckrodt markets products which include Nuclear Medicine products, Contrast Media, as well as finished pharmaceutical dosage products
- Demonstrable skills in reviewing and summarizing medical records
- Strong experience in computer applications such as Microsoft Word, Excel, Microsoft Access, and Power Point, and a willingness to expand and increase competencies
- Experience in writing safety summaries
9
Safety Scientist / Senior Safety Scientist Resume Examples & Samples
- Contribute to Pharmacovigilance and Risk Management planning for designated products
- Track and evaluate potential safety issues
- Perform Project Management activities for multiple studies in a program
- Support the SERM lead in the development and/or execution of RMP or REMS risk mitigation activities
- Prepare and review periodic aggregate safety reports (PADER, PSUR, DSUR, IND Annual Report, 6-month line-listings)
- Support the preparation and maintenance of safety sections of the Company Core Data Sheet
- Conduct/support signal detection and evaluation according to SOPs and guidelines
- Prepare Safety Evaluation Reports as necessary for safety signals or other issues (product quality)
- Provide safety content review of clinical protocols, study reports, ICFs and Investigator Brochures for designated products
- Provide review of SMC/IDMC Charters as needed
- Support the SERM Lead in responding to safety requests for assigned product(s) from Regulatory Authorities, Affiliates and other internal functions
- Represent Drug Safety in Study Team Meetings and/or Clinical Sub Team Meetings for designated product(s)
- Attend weekly SERM meeting to relay safety concerns raised in Study Team/Clinical Sub Team Meetings
- Medical/Clinical degree including MD, PharmD, BS Pharmacy, PA, or BS RN degree
- Minimum of 2-3 years of experience in industry in drug safety or clinical development
- Oncology safety science preferred
- Good Knowledge of US and EU pharmacovigilance regulatory requirements
- Good knowledge of pharmacovigilance practices and tools (e.g., databases, signal detection tools, MedDRA)
- Good medical and scientific judgement, attention to detail and excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
10
Associate Director, Patient Safety Scientist Resume Examples & Samples
- Work under minimal supervision on routine tasks
- Work on more complex processes, systems, projects and issues with supervision
- Identify risks and propose corrective actions in moderately complex situations
- Apply appropriate strategies and option based rationale
- Coordinate work with manager and Safety Lead for assigned products
- May provide training to project teams or at project related external meetings on medical issues or pharmacovigilance
- Provide scientific input in signal detection, strategy and evaluation
- Communicate without delay with SL if safety issues are identified Reviews of appropriate data from product complaints database for patient safety implications
- When applicable provides input into pharmacovigilance process improvement (eg, assigned member of process workstreams)
- Provide support to SL, Benefit Risk Team (BRT) for Global Labelling Committee (GLC), Benefit Risk Board (BRB), and PVU activities
11
Director, Patient Safety Scientist Resume Examples & Samples
- Be one of the safety experts for assigned products
- Apply best practices, principles and theories in moderately complex situations and issues
- Write and review, and when applicable, approve response to questions from competent Authorities
- Liaise with local safety officers (LSOs) and other affiliated personnel on responses to local authorities
- When applicable, be responsible for risk-benefit assessment for assigned products
- Fulfill required responsibilities of project team member and when delegated as project team leader (as determined by project governance: may participate in study team)
- When applicable, provide safety input and review to aggregate reports and ad hoc safety reports
- When applicable, provide input to safety operations
- Review and provide safety input for relevant clinical or regulatory documents for assigned products (IB, protocols, RMP, SmPC, US PI, PIL, EMA article 31s, FDA field alerts , and OSS/Recall Medical Assessments, etc)
- Produce accurate and fit-for-purpose signal evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data,
- Lead ad hoc pharmacovigilance projects
- If not a Physician, ability to know appropriate times to get medical input and review and to develop working relationship with other Patient Safety team members who are physicians
12
Patient Safety Scientist, Safety Compliance Resume Examples & Samples
- Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background
- 2-4 years of experience in pharmaceutical industry, with at least 2 years of pharmacovigilance experience (with drug safety regulations (i.e., FDA, EMA, MHRA, etc.), drug safety compliance, or pharmacovigilance agreements) and working in a pharmaceutical drug safety department
- Must be a knowledge resource-having a deep understanding of global and local processes and internal regulations on Adverse Event reporting
- Proven analytical skills
- Proven leadership skills with the ability to resolve conflict
- Prior experience with Safety Data Exchange Agreements (SDEA)
- Able to work with autonomy
13
Director, Patient Safety Scientist Resume Examples & Samples
- Provide training to project teams or at project related external meetings on medical issues or pharmacovigilance
- Liaise with local safety officers \(LSOs\) and other affiliated personnel on responses to local authorities
- Reviews of appropriate data from product complaints database for patient safety implications
- Fulfil required responsibilities of project team member and when delegated as project team leader \(as determined by project governance: may participate in study team\)
- When applicable provides input into pharmacovigilance process improvement \(e.g. assigned member of process workstreams\)
- Review and provide safety input for relevant clinical or regulatory documents for assigned products \(IB, protocols, RMP, SmPC, US PI, PIL, EMA article 31s, FDA field alerts , and OSS/Recall Medical Assessments, etc\)
- Provide support to SL, Benefit Risk Team \(BRT\) for Global Labelling Committee \(GLC\), Benefit Risk Board \(BRB\), and PVU activities
- Produce accurate and fit-for-purpose signal evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data
- PhD, PharmD, DVM or other relevant advanced degree
- Strong scientific/medical background
- Understands business and cultural drivers
- Skilled at operating in cross- cultural team environment
- Able to identify and resolve issues related to performance and/or understanding and can effectively deal with conflict/disagreement
- Ability to act as a company representative \(e.g. regulatory inspectors\)
- Proven diagnostic/analytical/evaluation skills with strong attention to details
- Able to see underlying or hidden medical problems and proactively take actions
- Able to understand and analyse clinical and medical data
- Knowledge and understanding of applicable regulations in pharmacovigilance and clinical development
- Maintains knowledge of industry trends and best practices
- Ability to extrapolate from known knowledge into new situations
14
Clinical Safety Scientist Resume Examples & Samples
- Reviewing initial assessment of likelihood of AE reports being received for new marketing programs through discussion with marketing program owner/Patient Safety
- Providing guidance and information to the business activity owner within Novartis on the requirements for collecting adverse event (AE) reports in accordance with the classification of their program
- Delivering AE training to Novartis associates and third party vendors to ensure compliance with AE reporting
- Managing and executing monitoring requirements for individual programs including reconciliation and source data verification activities
- Maintaining oversight of program compliance in accordance with local and global Novartis procedures
- Evaluation and Quality Control of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality
- Ensure accurate and consistent coding of medical history, drugs and adverse event terms
- Determine the necessity for follow-up and prepare follow-up request as needed
- Work in conjunction with Clinical Safety Associates, Clinical Safety Scientists from other processing sites and Medical Safety Experts to ensure that reports are accurately evaluated and databased
- Represent Patient Safety at internal and external meetings
- Play an active/leading role in cross-functional teams on safety matters/Patient Safety special projects relating to investigational and marketed drugs
15
In Vitro Toxicology / Safety Scientist Resume Examples & Samples
- Provide scientific leadership & technical contributions for in vitro safety toxicology in order to identify, investigate and derisk mechanisms of toxicity at all stages of drug discovery and development
- Provide screening tools to derisk safety liabilities identified in pre-clinical toxicity studies
- Supervise, organize and review laboratory activities with focus on high impact processes in line with the strategic goals of the team
- Train new scientists and integrate them into the laboratory work stream
- Work closely with and provide input to the scientific leadership team
- Lead a cellular and molecular toxicology laboratory
- Train and supervise postdoctoral and graduate students
- Implement and validate key in vitro safety toxicology studies identified by the team
- Support technology transfer of selected technologies and assays to external partners (eg CROs)
- Attend scientific congresses and support publication of abstracts and/or papers in scientific journals supported by a good publication record
- Provide support in establishing internal and external collaborations in the field of investigative, mechanistic safety toxicology and safety biomarkers
- Strong communication skills and the ability to work within cross-functional teams
- Support development of appropriate collaborations with external partners, academic institutions, CROs and consultants
16
Drug Safety Scientist Resume Examples & Samples
- Proficiency in triage and all case processing activities
- Computer literate with expert knowledge of Safety Database
- Ability to negotiate and communicate with internal and external customers
- Ability to work effectively as a member of the Drug Safety and broader Medical Department teams
- Knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland
17
Clinical Safety Scientist Resume Examples & Samples
- Review, manage and create case reports for all reportable events
- Ensure that all information required for a complete and accurate case is present
- Triage safety queries from the clinical team and medical safety review
- Generate safety queries to the trial investigator sites to ensure case report accuracy and completeness
- Prioritize daily work to ensure all events are submitted to case processing for entry into the safety database within the established timeframes
- Participate as an extended member of the Medical Monitoring Team.
- Reconcile critical data points between clinical and safety database
- Collaborate closely with cross functional colleagues in clinical development, clinical operations, medical safety review and case processing within HQ for AE/drug safety issues
- May collaborate with external colleagues, business partners or vendors
- May lead a team of junior colleagues or contract employees in support of a large complex trial
- May serve as an expert resource for less experienced colleagues
- May provide training /coaching for new employees
- May serve as a subject matter expert (SME) for a process, program, case type or therapeutic area
- May participate in cross-functional or internal initiatives and/or process improvement projects
- Education: Medical Doctor
- Experience: 1 year of clinical work experience in a patient care setting
- Strong understanding of scientific and medical concepts
- Basic understanding of drug development
- Knowledge of GCP and ICH regulations
- Experience working as part of a cross-functional team setting
- Effective problem solving skills
- Must have excellent project management, and time management/organizational skills
- Strong communication skills with advanced oral and written English skills
- Advanced computer/database skills
18
Safety Scientist Serm Resume Examples & Samples
- Bachelors level or above degree in a biomedical or health care-related specialty
- 2-3 years clinical safety experience or equivalent experience ( e.g. clinical development in a pharmaceutical company, regulatory authority etc.)
- Basic understanding of safety evaluation methodology/ process awareness of pharmacovigilance regulations and methodologies
- Understanding of medical terminology
- Experience in drafting responses to ad hoc queries or evaluating significant safety issues for regulatory submissions (e.g., PSURs ) under supervision
- High degree of accuracy with attention to detail
- Detail oriented, methodical and analytical approach
- Good communication skills, team player, flexible
- Ability to manage crisis, monitor safety issues and work under pressure with a customer and solution oriented approach
- Able to prioritize activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
- Demonstrate initiative and creativity in performing task and responsibilities. Proactively contributes ideas to improve existing operations
- Demonstrated writing skills
- Computer literate, familiar with using scientific and clinical databases
19
Senior Drug Safety Scientist Resume Examples & Samples
- Awareness of and familiarity with industry principles of drug development and pharmacology
- Ability to prioritise and work to strict timelines on a daily basis
- Thorough knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland
- Local Subject Matter Expert in Global Safety Database
- Proven expertise and experience in pharmaceutical regulations and R&D processes
- Degree-level qualification (ideally in life sciences) or equivalent nursing qualificationDrug & Product Safety Science
20
Clinical Safety Scientist Resume Examples & Samples
- Review publications from the scientific and medical literature for important safety information; summarize and critically appraise the findings from these publications for safety reports (such as periodic safety update reports, signal detection reports, signal evaluations)
- Drafting of safety-related documents, particularly sections relating to safety risk management e.g.periodic safety update reports, , development safety update reports, clinical overview addenda to support registration activities; and contributing to/ reviewing safety sections of other clinical or regulatory documents including Investigator’s brochures and submission dossiers
- Contribute to the production of, and updates to, Risk Management Plans for CSL manufactured products, including drafting of the safety sections
- Support ongoing risk management activities by participation in and coordination of the operational and scientific activities associated with internal cross functional Safety Management Teams for the associated products
- Participate in associated development teams, such as the Study Execution Team and the Clinical Development Team, in collaboration with the Clinical Safety Physician
- Support the physician in providing responses for safety-related questions from internal sources and/or external regulatory requests
- Bachelor’s degree required in the biological or pharmaceutical sciences
- Advanced clinical/scientific degree preferred
- Clinical research experience within the pharmaceutical industry is required
- Understanding of ICH GCP and drug development preferred
- Excellent written and verbal communication skills in English, with the ability to evaluate, interpret and synthesize scientific data
- Self-motivated, able to prioritize and plan effectively
- Ability to work independently and as team player, working in a global cross functional environment
21
Clinical Safety Scientist Resume Examples & Samples
- BSc or equivalent - biomedical sciences, pharmacy or nursing fields preferred
- High degree of accuracy and attention to detail when working within required timelines
- Understanding of medical and drug terminology
- Demonstrated planning and organisational skills
- Good judgement and problem solving ability
- Demonstrates independent self-motivated approach to working
- Proven ability to function effectively in a team environment recognising the needs of the business, the team and individual team members
- Previous pharmacovigilance experience is desirable,
- Knowledge of GCP, clinical safety documentation, reporting of adverse events and regulatory requirements
- Working knowledge of principles of data collection, manipulation and retrieval
- Data Entry/Processing adverse event and pregnancy reports from clinical trials, literature and spontaneous sources in accordance with GSK standard operating procedures and performing appropriate follow up activities
- Preparing reportable cases, including expectedness assessments for regulatory reporting to the EMA
- Liaison with study monitors and safety personnel in GSK operating companies with regards adverse event reports and clinical trial operations
- Performing reconciliation activities for clinical trial data
- Providing input into guidance documents and process improvement initiatives
- Review of scientific and medical literature to extract relevant adverse event case information
22
Senior Principal Patient Safety Scientist Resume Examples & Samples
- Technically fully competent to perform all usual Senior Patient Safety Scientist workload, including case report QC, review, follow-up and reportability assessments and input into aggregate safety reports, with the flexibility of mindset this requires
- Liaise with other relevant functional areas both within and outside of global GPSE to best ensure the most efficient and timely attainment of compliant and patient focused safety data
- Represent patient safety department in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires
- Expect close interaction and involvement with senior GPS physicians and the safety Therapeutic Area Lead (TAL), particularly when the responsible GSL
- Provide support and oversight of patient safety operational activities for designated compounds, with lead responsibilities when acting as the GSL
- Mentorship and guidance for less experienced colleagues within the department
- Bachelor’s degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD)
- Ability to review, analyze, interpret and present complex data to a high standard
- Good level of computer literacy
23
Safety Scientist Resume Examples & Samples
- Knowledge of the clinical areas for which Mallinckrodt markets products which include Contrast Media, as well as finished pharmaceutical dosage products
- Knowledge in the review and analysis of the medical literature
- Excellent verbal and written communication skills including excellent telephone etiquette. Must be comfortable handling discussions with patients and health care providers on health and medical topics
- Extensive experience in the reporting as well as managing of adverse event reports
24
Senior Food Safety Scientist Resume Examples & Samples
- The investigation and recommendation of corrective and preventative actions for Q&FS incidents
- Team backup for the Food Safety Management Scientist
- Acting as subject matter expert, including internal operations processes and systems, to promote transfer of best practice within Mars
- A true grasp of continuous improvement
- A robust drive for results
- Real commitment to teamwork
25
Safety Scientist Resume Examples & Samples
- Author and coordinate/project manage development of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc) in accordance with Kite SOPs and regulatory requirements
- Support preparation and maintenance of Risk Management plans
- Contribute to development of signal detection strategy for post marketed products
- Support signal detection, evaluation and management according to Kite SOPs and guidelines
- Support development and/or maintenance of core and local label for Kite products (e.g., CDS, USPI, SmPC, IB, etc)
- Serve as the Safety Lead for one more Kite clinical programs
- Provide safety content review of clinical protocols, CSRs, and ICFs
- Ability to critically analyze individual and aggregate safety data with scientific rigor
- Strong relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting
- Excellent written and verbal communication skills to a variety of levels and teams, internally and externally
- Ability to operate objectively and independently as a leader and as a member of a team, as required
26
Safety Scientist Resume Examples & Samples
- Assist with the preparation of adverse event reporting plans (AERPs) and other
- Review project specific proposals, pricing and protocols to ensure consistency
- Ensure the quality and accuracy of data used to support any
- Registered Nurse, Pharmacist, or other degree in a
- Fluent in English, additional language fluency a plus, but
27
Senior Clinical Safety Scientist Resume Examples & Samples
- At least 3 years experience as a clinical safety scientist or equivalent position in a closely related discipline
- Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines and standards
- Knowledge and experience of safety monitoring and signal detection preferred
- Computer proficiency in basic database entry and graphics presentations (e.g. Microsoft Excel or equivalent)
- Ability to work independently and as team player, working in a cross functional environment
28
Drug Safety Scientist Resume Examples & Samples
- Proficiency in global and local SOPs
- Computer literate with expert knowledge of the Global Safety Database and/or expedited reporting module(s)
- Committed to caring
29
Safety Scientist Resume Examples & Samples
- Prepares high-quality narrative summaries for expedited safety reports incl. responsibility to ensure all safety information is accurate, integrated and current, and is submitted within regulatory timelines
- Participates in the evaluation of serious adverse event reports from spontaneous reports, clinical trials, non-clinical reports and scientific literature
- Provides technical support to GPV&E medical review safety physicians (MRSP) including review and interpretation of source documents
- Identifies additional information required from investigators and collaborate with MRSP to prepare queries to obtain additional information
- Utilizes safety and clinical databases to prepare contextual summaries for expedited safety reports
- Coordinates all activities around the preparation, evaluation, review and submission of expedited safety reports
30
Food Safety Scientist Resume Examples & Samples
- PhD in Microbiology or Master/Engineering Degree with 5-10 years of experience in working in an industrial setting, R&D, Operations or in a Research association/Research Institute
- Strong and broad background in molecular biology, food microbiology, pathogenic germs, environmental contaminations, spoilage contaminants
- Experience in leading projects in a complex environment. Experience in cheese or related industry would be appreciated but not a must
- Ability to follow science, but focus on the application
- Ability to work both independent and in cross functional teams
- Able to take initiatives but team player and Service oriented
- Strong interpersonal skills, able to communicate and to build connections & networks
- Ability to work in a changing environment
- Acting with passion and integrity. Being open and committed
- Ability to solve problems creatively
- Structured way of working, project oriented, focused on tasks and deadlines
- Fluent English (work language), good level of French is an advantage
31
Drug Safety Scientist Resume Examples & Samples
- Master degree or above in clinical medicine, pharmacy or a life/biological science
- Good interpersonal communication skill
- Good command of both English (written and spoken) and Chinese (written and spoken)
- Good computer skills including proficiency with Microsoft Word, Explorer and Outlook and familiarity with the internet
- Good at teamwork
- At least 6 to 8 years working in Health Industry
- Knowledge of local regulatory environment and PV system
- Sound knowledge of therapeutic areas assigned
- Familiarity with ICH E2 guidelines and relevant local regulations
- At least 4 years Pharmacovigilance working experience in multinational pharmaceutical company
- In depth of understanding and experience of causality assessment, signal detection and proactive risk minimization activities
- Knowledge of other relevant disciplines
- Clear understanding of drug development process and approval process in China
32
Medical Safety Scientist Resume Examples & Samples
- Medical evaluation of individual adverse event case safety reports,including but not limited to all serious and expedited reports in clinical study or marketed environment; S/he should have ability to learn from GMS initially to make individual case assessment and evaluation in China R&D clinical project or ad hoc project
- Accountable for clinical safety review, recommendation and interpretation, analysis and summarization of aggregate safety data and periodical data from all sources including spontaneous, clinical, postmarketing and observational studies, literature review and product quality (e.g. safety summary and regulatory inquiry etc) per regulations and the requirements
- Provide therapeutic area/pharmacovigilance issue and guidance in single case assessment and ensure proper communication with project team
- Participate local labelling review activities and meetings for execution of pharmacovigilance components of Risk Management Programs and related activities including assessment of potential signals
- Participate as core members of crisis management responsible for pharmacovigilance activities focused on individual products and pertinent therapeutic areas; Responsibilities include training activities, contributing to the development and implementation of risk minimization action plans
- Degree/Advanced degree in clinical medicine or pharmacy, appropriate post-medical degree / specialty accreditation strongly preferred
- Drug safety experiences in PV or clinical research or drug development in international pharmaceutical companies at least 4-6 years
- Good problem solving and decision making skill
- Strong interpersonal skills, with a demonstrated ability to foster team work
- Ability to manage discussions and decision making
- Excellent communication, conflict management and negotiation skills
- Good English/Chinese communication skill (written and verbal)
- Opening, optimistic and easy going personality
- Good computer application skills.1700163055W
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Global Patient Safety Scientist / Manager Resume Examples & Samples
- Excellent technical, analytical and problem solving skills
- Strong understanding of data structure of PV database
- Presentation, organizational and interpersonal skills are a requirement
- Excellent interpersonal skills that encourage teamwork
- Advanced knowledge of medical and clinical terminology
- Broad knowledge of ICH guidelines, as well as FDA and EU Regulations
- Experience with commercial databases and safety coding dictionaries (MedDRA, WHOART, COSTART, etc.)
- Scientific/Technical Analysis: Provide guidance to internal project teams in the area of design and analysis for routine projects
- Submission/Project Management: Oversee the preparation, planning, coordination, execution, confirmation and ongoing maintenance of AE reports
- Communication with Regulators/Customers: Provide technical review of PV documents (i.e., case files)
- Bachelor’s degree in a scientific/medical discipline. Advanced degree preferred
- 5 years of experience in a pharmaceutical industry setting, including roles as both an individual contributor and as a participant/leader in a team environment
- Minimum of 2 years of previous experience in Patient Safety or related position (e.g., Safety Operations, Safety Data Management)
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Senior Principal Patient Safety Scientist Resume Examples & Samples
- Liaise with other relevant functional areas both within and outside of global PV to best ensure the most efficient and timely attainment of compliant and patient focused safety data
- Represent pharmacovigilance department in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires
- Provide support and oversight of pharmacovigilance operational activities for designated compounds, with lead responsibilities when acting as the GSL
- Lead set up of safety procedures for complex developmental programmes
- Ability to review, analyse, interpret and present complex data to a high standard
- Global player in a global PV organisation
- Excellent organisation skills and ability to prioritize
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R&D Senior Food Safety Scientist Resume Examples & Samples
- Work closely with the G&C BU to develop key microbiological related strategic initiatives that both ensure brand protection & contribute to business growth. Develop action plans to support these strategies to deliver business objectives
- Provide scientific and technical microbiological support to the BUs to ensure product quality and safety. Proactively identify and communicate micro and other food safety risks to senior management, giving actionable scientific advice on risk management and risk communication. ---Ensure Food safety programs for G&C reflect most updated known scientific information
- Partner with R&D to ensure appropriate product design for safety and quality. Continuously improve and adapt the relevant HACCP models & policies to reflect current knowledge, working with other regions and FS team members. Develop new models as appropriate
- In co-operation with SARA, Auditing, Category Quality and Ops, leverage the company position with advisory, regulatory, governmental and scientific bodies by building and maintaining comprehensive communication networks and scientific contact points for retrieving and verifying significant microbiological information with business impact. This position will understand through benchmarking company position in relation to other large organizations on key food safety programs
- This position will provide expert advice to validate effectiveness of new technologies that provide both food safety and other functionalities and actively co-ordinate these activities with G&C R&D organization
- Proactively implement globally (e.g. in company standards) lessons learned in microbiology and food safety to improve business performance
- Continuously improve own micro & food safety related knowledge, skills and understanding of food microbiology, epidemiology and food hygiene matters. Continuously improve own performance by upgrading skills and identifying/using skill-enhancing assignments, courses and training opportunities, as well as networking opportunities to ensure up-to-date knowledge
- Develop appropriate training for functions in the area of microbiology and food safety. Act as mentor to new employees in FS and MDLZ & MEU Quality functions
- BS/MS/PhD the areas of microbiology and food science/engineering/food technology
- MSc or PhD in Microbiology or closely related field
- Experience with implementation and monitoring of microbiological food safety programs, including PEM, zoning, CCPs, and good manufacturing practices relevant for microbiological safety
- Recognized as an expert in Biscuits microbiological food safety internally
- Demonstrated ability to accomplish objectives on assignments which have ambiguity associated with their procedures, solutions, approach, etc
- Excellent communication skills (presentations, report writing)
- Excellent Organizational skills including time management and priority setting
- Excellent influencing skills
- Fluent English is a must
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Safety Scientist Resume Examples & Samples
- Writing of procedural documents such as Adverse Event Reporting Plans (AERPs)
- Adverse Event case processing: receipt, data entry, coding, and evaluation of Adverse Event reports according to the applicable SOPs, including writing the narrative; perform seriousness, listedness and causality assessment
- Monitor compliance and ensure appropriate documentation (metrics, deviations)
- Assist in evaluation and validation of systems to support safety e.g. supporting the development teams in safety database configuration and EDC specifications
- Performing global and local literature review
- Project oversight and identification of issues. Escalation
- Registered Nurse, Pharmacist, or other Life - Science degree
- Comprehensive knowledge of EU, ICH and FDA Regulations and Guidelines both clinical and post marketing
- Experience in pre and post marketing Pharmacovigilance
- Experience in literature review
- Experience in case processing and PV regulatory reporting activities
- Experience in data entry in ICH E2B compliant database
- Knowledge of database management a plus
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Senior Safety Scientist Resume Examples & Samples
- Compiles and analyzes safety data for inclusion into aggregate reports and safety analyses; evaluates impact to benefit/risk in conjunction with medical director(s)
- Proactively investigates trends in safety data and follows scientific methodology and logical reasoning to determine cause/effect and potential prevention of adverse events. Reports findings to management and assigned medical director
- Evaluates signals using available signal tools including use of external epidemiological databases, review of scientific literature and pharmacovigilance safety data. Considers impacts to benefit/risk assessment and risk characterization and incorporates into relevant documents (i.e. PBRER, RMP)
- Ensures timely communication of potential safety signals through surveillance activities to line management
- Conducts analyses within the aggregate reports group with a systematic scientific approach which allows for a consistent review of all products using the same methodology
- Collaborates with PV Medical Directors, Safety Surveillance, and Safety Systems on all activities to support preparation of aggregate reports, risk characterization and signal detection
- Leads coordination of signal assessment activities with Safety Committee members including compiling source data, scientific interpretation and presentation of data for analysis
- Leads efforts in strategy & research of literature and drug databases and compiles source data for aggregate review in evaluation of signals
- As subject matter expert, prepares and presents safety data to management and Lundbeck’s Safety Committee
- Collaborates with cross-functional teams and provides safety information to assist in labeling review and safety committee review meetings
- Ensures expertise is pharmacovigilance and scientific area by keeping current and communicating information from relevant scientific literature, regulations, courses and conferences
- Manages and tracks signal detection activities collaborating with medical directors to accurately track open, refuted and closed signals and documentation of important and potential risks for continuity of safety surveillance activities
- Contributes in the review of the overall safety profile and risk/benefit profile of marketed products and drugs in development at specified intervals per SOP
- Ensures regulatory compliance by providing timely, quality information for aggregate reports and signal review following SOPs and regulations
- Monitors report deliverables/timeline working with cross functional groups and adjusts project timeline accordingly
- Contributes to the development of standard operating procedures and pharmacovigilance processes for aggregate report and signal detection activitie
- Bachelor’s degree in Health Science, Pharm D, Nursing or related healthcare degree
- 5+ years of experience in one or more of the following areas; pharmacovigilance, clinical research, medical affairs or medical writing
- Knowledge of regulations and guidance (US and global) governing pharmacovigilance practices
- Ability to analyze safety data in aggregate from multiple sources
- Sound understanding of pharmacovigilance safety surveillance activities
- Expertise with critical appraisal of scientific medical literature
- Working knowledge of MedDRA
- Proven ability to produce aggregate safety reports (PSUR/PBRER, DSUR, signal evaluation reports)
- Ability to work well with minimal supervision in a fast-paced environment
- Excellent medical/technical writing skills
- Strong oral and presentation skills
- Experience with Microsoft Office applications
- Graduate degree in health sciences, Public Health
- Knowledge/experience with safety database and use of external databases such as FOI, Vigibase
- Project management experience beneficial
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HEL Safety Scientist Resume Examples & Samples
- Candidate must have a BS in Chemistry or Chemical Engineering or an advance degree in Chemistry or Chemical Engineering with related industrial experience in process development or hazard evaluation
- Pharmaceutical industry experience is preferred
- Strong technical skills (chemistry, chemical processing equipment, calorimeters), with previous experience in safety testing, hazard evaluation, plant operations, process development and scale up, and clinical material manufacturing are also desired
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Drug Safety Scientist Resume Examples & Samples
- Ensure all processes as described are operational
- Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings
- Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment reports
- Perform literature review for identification of case reports and other relevant safety information
- Review/Quality check (QC) of source documents, coding, data entry, report generation and distribution
- Monitor compliance metrics and ensure appropriate documentation when deficient
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Patient Safety Scientist Resume Examples & Samples
- BS degree preferably in biosciences or appropriate healthcare or pharmaceutical industry background
- Regulatory Submissions Experiences
- Basic competence with medical and therapeutic terminology
- Able to work independently, guided by procedures, with appropriate support
- Able to work effectively as part of a team
- An understanding of the US FDA and international regulatory requirements for single case expedited reporting and periodic updates
- Demonstrable communication skills; fluent in English (written and verbal)
- Maintains high ethical standards, including a commitment values and behaviors
- Good time management
- Project Management Experience (desired)
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Clinical Safety Scientist Resume Examples & Samples
- Degree in life sciences or medically related field
- 1-2 years’ clinical safety
- Knowledge of GCP, clinical safety documentation, and reporting of adverse events
- Basic safety database search skills
- Excellent skills in rapid and accurate data entry
- Health care professional (e.g. pharmacist or nurse preferred)
- Knowledge of GSK products
- Good understanding of MedDRA coding
- Knowledge of local regulatory requirements and pharmacovigilance methodology
- Sound organization skills
- Demonstrates planning and organizational skills
- Attention to detail but demonstrates pragmatism where appropriate
- Proven ability to handle high volumes of work accurately and rapidly
- Identifies issues/concerns in a timely and appropriate manner
- Self-motivated and capable of working independently
- Review, extract, and accurately enter AE data from marketed product, adverse event reports received from spontaneous and solicited (PMS) sources including health professionals, sales representatives, consumers and drug information in accordance with defined case handling procedures
- Review, extract, and accurately enter all serious AE information from clinical trial reports in accordance with currently defined case handling procedures
- Interpret case-related information including AE coding, medical conditions, lab results and procedures, as well as compile complete narrative summaries
- Ensure proper coding of AE terms and other medical terms using MedDRA into the global safety database
- Process and prepare cases independently within applicable timelines
- Meet specific data and quality targets for case handling
- Follow-up of US AE reports: Correctly identify cases requiring targeted follow-up, determine relevant follow-up required including phone calls and prepare follow-up letters/requests
- Review, enter, and verify follow-up information for cases
- Perform routine and ad hoc searches of the database for internal compliance, matching follow-up, and follow-up schedules. Electronically generate routine reports from the database
- Interact with colleagues in SERMs, Clinical Operations, Regulatory Affairs and Operating Companies as necessary
- Perform reconciliations of AE/pregnancy data
- Ensure compliance with safety data exchange agreements and CROs
- Demonstrate in-depth working knowledge of regulatory environment
- Assist in training department members
- Work with departmental teams in maintaining and upgrading the safety database
- Provide input to improve process documents and SOPs and represents local perspective in procedure discussions
- Process and prepare reportable cases independently within applicable timelines
- Maintain knowledge of SOPs, process documents and the GSK global safety database
- Maintain certification and training materials
- Monitoring of FDA late reports and E2B failures via the Worklist in Argus
