Drug Safety Associate Resume Samples

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T Muller

Tania

Muller

736 Bahringer Landing

San Francisco

+1 (555) 960 2811

736 Bahringer Landing

San Francisco

Phone

p +1 (555) 960 2811

Experience Experience

San Francisco, CA

Drug Safety Associate

San Francisco, CA

Witting-Reichert

San Francisco, CA

Drug Safety Associate

Responding to clients/customers in a timely manner
Maintaining an awareness of the performance metrics measured by client and striving to remain within established limits
Interacting with internal or external contacts to resolve issues related to the processing of cases and PQCs
Maintaining an excellent knowledge of case processing conventions and guidelines, client’s procedures and international drug safety regulations
Creating/generating AE/Product Complaint forms in the Product Complaint System
Working knowledge and familiarity with medical terminology
Identifying areas of concern within the team and raising the issues with the Team Lead

Dallas, TX

Drug Safety Associate, Case Processing

Dallas, TX

Hilll Group

Dallas, TX

Drug Safety Associate, Case Processing

Triage of incoming cases to prioritize for daily workflow management
Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
Preparation of SUA summary: Analysis of Similar Events
Performing single case creation/initiation in the safety database
Keeping track of the Product Quality Complaints
Maintaining a good working knowledge of the AE safety profile of assigned products and labeling documents
Maintaining a good working knowledge of the AE safety profile of assigned drugs and labeling documents

present

New York, NY

Senior Drug Safety Associate

New York, NY

Douglas-Harvey

present

New York, NY

Senior Drug Safety Associate

present

Assist in the safety management activities for Five Prime Sponsored Clinical Trials
Project management or Lead DSA assignment is a plus
Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
Strong attention to detail, teamwork and take initiative
Working knowledge with at least one major safety database system (e.g. Argus, ARIS-g)
Assist with periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies
Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information

Education Education

Bachelor’s Degree in Life Sciences

Quinnipiac University

Bachelor’s Degree in Life Sciences

Skills Skills

Strong knowledge of Swiss legislation & regulation
Detail-oriented, customer- and quality-focused
Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions
Good knowledge of medical terminology
Detail orientated and capable of working effectively within a team environment
Attention to detail and quality
Good communication ability both in English and Mandarin
Computer proficiency, an ability to work with web-based applications
Ability to work independently and within strict timelines

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10 Drug Safety Associate resume templates

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Drug Safety Associate Resume Examples & Samples

Minimum of BSc in life sciences with at least 2 years drug safety experience in a pharmaceutical or CRO environment
Experience in Phase I through Phase IV clinical trials with knowledge of drug safety regulations and industry standards
Experience with an accepted clinical data capture and management system is preferred
Strong verbal and written communication skills with the ability to understand and summarize medical terminology
Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
Detail-oriented, customer- and quality-focused
Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions
Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
Contribute to the preparation and review of additional regulatory reporting documents (i.e., IND/DSUR/Annual Reports), or other documents, as necessary
Actively participating in internal, external, and client meetings or audits
Plan and manage deliverables and timelines in accordance with clinical trial project teams' requirements
Keep current with industry best working practices in PV guidance(s) and regulations

UBC Senior Drug Safety Associate 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

Drug Safety Associate Resume Examples & Samples

Investigates, evaluates, and follows up on case reports associated with safety of investigational and marketed drugs
Reviews medical and scientific literature for reports of adverse events
Performs coding of adverse drug experiences using MedDRA and drugs using the WHO Drug Dictionary
Prepares expedited and periodic case reports for marketed drugs (NDS/ANDAs) for submission to the FDA
Gathers complete SAE information and prepares expedited case reports associated with investigational new drugs (INDs) for FDA submission and dissemination to study sites
Contacts study sites for follow-up information on clinical SAE cases
Participates in SAE reconciliation between the safety and study databases
Provides guidance in handling and processing SAEs to clinical study sites
Responds to product safety queries
Participates in clinical team meetings and other safety related meetings
Communicates with clients regarding project issues regularly
Handles incoming calls, facsimiles and email from healthcare professionals, the general public and others to answer specific questions pertaining to pharmaceutical products
Performs literature searches using Pubmed and other databases to help answer questions received by healthcare professionals
Reads and reviews scientific literature related to supported products such as books, manuscripts, publications and marketing communications
Updates standard responses on a regular basis
Maintains product information programs as needed
Identifies calls pertaining to adverse events and product complaints and triages those calls as appropriate
Performs other assigned duties as required
Must be an MD
Degree in Nursing, Pharmacy, medical field or other allied healthcare field helpful
Two- three years’ experience in drug safety in the pharmaceutical industry or other comparable experience
Experience in medical care and clinical operations
Must be able to function independently and as a team member
Ability to execute assigned tasks and meet assigned milestones
Knowledge of FDA and ICH regulations related to drug safety
Proficient in word-processing, database and spreadsheet software

Drug Safety Associate Resume Examples & Samples

As a DSA, you will be expected to prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, and Principal Investigators and business partners
Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information
Medical/science background and/or bachelor’s degree or local equivalent

Senior Drug Safety Associate Resume Examples & Samples

Bachelor or above degree in medical/science background (nursing preferred)
Be with the experience in PV and Safety Services at least 2 years
Good communication ability both in English and Mandarin

Drug Safety Associate Resume Examples & Samples

Perform initial evaluation of reported adverse events (serious and non-serious) from all sources
Perform case entry and verification of reported non-serious and serious adverse events; enter the reported information in the Novo Nordisk safety database, on the basis of individual case histories, correspondence with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments
Ensure accurate and consistent coding of all events for serious and non-serious cases entered in the Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities)
Evaluate causality, seriousness and listedness for all cases
Ensure that case narrative comprises correct and appropriate safety information
Assess the need for follow up information and issue follow up requests for all cases and post queries in EDC and/or to affiliate
To be responsible for Periodic Safety Update Report (PSUR) clean up and other case clean-up activities
Ensure that all tasks are performed in compliance in accordance to GXP requirements
Maintain a network of safety contacts within Global Safety (GS) and affiliates
Participate in projects in Global Safety or in other parts of the organisation with impact in Global Safety processes
Liaise with affiliates and partners for local literature and compliance
Liaise with Safety Reporting and IT in all aspects of data retrieval and custom reporting
Participate in inspections and audits when required
Assist with related administrative and procedural activities as required or requested
Independent decisions making regarding evaluating the submission of adverse event reports
Ensure compliance with the training plan provided for the role
Act as a buddy for colleagues and provide trainings as required
Good communication skills (written and oral), with English correspondence
Basic working knowledge of MS Windows applications including MS Office tools
Basic knowledge of Pharmacovigilance and medicinal terminologies and Clinical Pharmacology
Basic knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety
Basic Novo Nordisk organizational or pharmaceutical company understanding
Basic knowledge of Novo Nordisk products, incl. mechanism of action, safety profile, patient population, etc
Self-motivated and proactive
Quick learning and analytical skills
Ability to take up initiatives
Team oriented personality with high degree of flexibility
Ability to capture attention and motivate a team around discussion
Ability to work independently and within strict timelines
Attention to detail and quality
Willingness to occasionally work at unusual times
Strive for continuous improvement

Drug Safety Associate Resume Examples & Samples

Triage of incoming reports for completeness, legibility and validity
Initial data entry of case reports into safety database / tracking system
Assessment of case reports for seriousness, causality and expectedness
Requesting follow-up i.e. written, telephone
Adverse event (AE) and drug coding
Assist with additional Drug Safety Specialist activities as required
Inform Medical Project Managers and Regional Head of PV Operations of potential change-in-scope of projects
Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as
Understanding of drug safety and the drug development process
Excellent verbal / written communication skills
Experience with basic computer applications

Drug Safety Associate Resume Examples & Samples

Performing clear and accurate data capture of Individual Case Safety Reports (ICSRs) (including serious and non-serious cases from spontaneous and clinical trials origin, literature and E2B cases; and veterinary cases, as applicable) and appropriate medical assessment (including company causality and assessment of expectedness) of ICSRs in accordance with client conventions/guidelines and Standard Operating Procedures
Reviewing ancillary documentation accompanying ICSRs and identifying the relevant information for processing and electronic capture on the client’s safety database
Maintaining an excellent knowledge of data capture conventions and guidelines, client’s procedures and international drug safety regulations
Maintaining a good working knowledge of the AE safety profile of assigned drugs and labeling documents
Ensuring MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”
Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Interacting with internal or external contacts to resolve issues related to the processing of ICSRs
Responding to clients/customers in a timely manner
Performing triage of literature abstracts and/or full articles for validity
Performing single case creation/initiation in the safety database
Mentoring new recruits in the team, if required
Identifying areas of concern within the team and raising the issues with the Project Manager
Maintaining an awareness of the performance metrics measured by client and striving to remain within established limits
Good knowledge of medical terminology
Fluency in written and spoken English and Japanese
Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Operating System and the MS Office suite (Word/Excel/Power Point)
Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
Typing and transcription accuracy
0-4 years

Drug Safety Associate Resume Examples & Samples

Assist in development of project specific safety procedures, workflows and templates
Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing
Triage incoming reports for completeness, legibility and validity
Request follow-up and perform query management
Coding of data in the safety database
Assistance in development of Expedited Reporting Procedures
Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor
Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
Submission of safety reports to investigators via ISIS (International Safety Information System)
Assist with measuring investigative site performance in conducting required tasks in ISIS
Tracking and filing of submission cases

Drug Safety Associate Resume Examples & Samples

Able to perform database/literature searches
Experience with computer applications ie.Argus or Aris G
Related experience gained in a healthcare environment is an advantage

Senior Drug Safety Associate Resume Examples & Samples

Manages and lead activities in specific projects as assigned with minimal guidance
Provides informal guidance to junior staff and act as a resource when needed
Creates or updates local SOPs/WIs as required
Works independently; receives minimal guidance
Solves complex problems; takes a new perspective using existing solutions
Represents the level at which career may stabilize for many years or even until retirement
Trains and mentors new associates
Follows Teva Safety, Health, and Environmental policies and procedures
Other projects and duties as required/assigned
3-5 years of drug safety, clinical or healthcare experience

Drug Safety Associate Resume Examples & Samples

Processes adverse event information received by the Drug Safety and Pharmacovigilance department
Performs accurate computer data entry of identified adverse event information and ensures the uniform and timely processing and reporting of adverse events to regulatory authorities
Adheres to company templates and guidelines for documentation and communications
Performs quality control activities to ensure complete and accurate case information has been entered into the drug safety database
Follows company processes and guidelines for case management and closure activities
Act as a liaison with internal departments and external business partners on Drug Safety and Pharmacovigilance operation management issues and clinical study related activities
Distributes completed regulatory reports to RA, ClinOps and other as needed to meet regulatory reporting timelines
Distributes reports via EVWeb
Ensures compliance with corporate and departmental standard operating procedures and completion of all assigned training on company procedural documents (5% Time)
Assist with special projects under the direction of the Drug Safety and Pharmacovigilance department management
My take on additional responsibilities in PV, for example signal detection support or Standards & Agreement support for PV Management
May act as the PSMF Administrator or back up
May assist in coordinating the department’s workflow
May be involved in the writing of SOPs and Work Instructions
May mentor DSA 1 & 11 employees
Participation in Inspections and Audits as identified
Personal Development

Drug Safety Associate Resume Examples & Samples

Awareness of European Post-Marketing legislation and requirements, namely QPPV and PSMF
Experience with computer applications
Previous experience in pharmacovigilance is required

Drug Safety Associate Resume Examples & Samples

Processes adverse event information received by the Drug Safety and Pharmacovigilance department (75%-85% Time)
May distribute completed regulatory reports to RA, ClinOps and other as needed to meet regulatory reporting timelines
May distribute reports via EVWeb
Other duties as required: (15% -25%Time)
May assist in coordinating the department’s workflow and assist with special projects under the direction of the Drug Safety and Pharmacovigilance department management
May mentor DSA I employees

Drug Safety Associate, QC Focus Resume Examples & Samples

Performs quality control activities including Oversight QC to ensure complete and accurate case information has been entered into the drug safety database, and provides feedback to team members
Helps monitor the QC workload to ensure compliance with business partner and regulatory requirements
Helps identify areas for process improvement (specifically regarding quality) and possible areas for retraining for individuals/team
Reviews case information for appropriate distribution to internal and external business partners
Reviews adverse event information received for completeness and consistency, initiates case follow-up activities/AE query management, and independently generates narratives in accordance with department processes
May triage incoming cases to determine seriousness for processing and reporting prioritization at the discretion of the Drug Safety and Pharmacovigilance department management
May participate in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures
Ensure compliance with corporate and departmental standard operating procedures
As an individual contributor, may serve as a project manager for functional projects or workflows
Performs other activities as directed by Drug Safety and Pharmacovigilance management
Experience in safety case processing as well as quality review of individual case safety reports, both in-process and via sampling, is preferred
Experience using Argus or other safety database applications
Experience using MedDRA  Excellent oral and written communication skills
Highly organized and demonstrates consistent attention to detail
Must demonstrate accountability for delivery of results and have good problem-solving and decision making skills
Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
Must have the ability to work collaboratively as part of a team in a fast-paced dynamic environment
Requires a health care professional background, either nurse or PharmD and a minimum of 3 years drug safety experience, or
BS/BA degree in a health related or biological science related field and 5 years of drug safety experience, or
Knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to resolve issues

Drug Safety Associate Resume Examples & Samples

Attend project team meetings and teleconferences as required
Assist with training/mentoring newly hired DSA staff, as requested
Assist with identifying out of scope activities in conjunction with the MSS Functional Lead
Assist with generation of study specific procedures
Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues
Liaise with ICON project manager, and other departments, as appropriate
Assist the MSS Functional Lead under supervision
Act as lead DSA for local or regional projects
US/LATAM/CAN:A minimum of 1 year of relevant clinical research / pharmaceutical industry experience, preferably in pharmacovigilance / drug safety
Knowledge of medical terminology and coding systems
Basic computer skills (Microsoft Word, Excel, Outlook, Access)
Medical/science background (nursing preferred) and/or bachelors degree or local equivalent

Drug Safety Associate, Taiwan Resume Examples & Samples

Ensures that an after-hours process is in place, tested at least once every 3 months and results are documented
Maintains up- to-date information on local Regulatory Authority out of hour’s contacts
Medical, pharmacy or life-sciences degree (or equivalent)
Minimum of two years’ experience working in the pharmaceutical industry in a drug safety role is strongly preferred for the Affiliate Safety Representative role but is less critical for the backup ASR role
Excellent written and spoken communication and presentation skills
Fluency in written and oral English is essential in order to facilitate communications with Pharmacovigilance and Patient Safety, Regional Medical and other headquarters functions
Fluency in written and oral local language a requirement in order to facilitate communications within the affiliate medical department, and with the National Regulatory Authority
Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
Sound judgment, strong planning and organizational skills, and the ability to get things done
Demonstrated strong sense of urgency

Drug Safety Associate Resume Examples & Samples

Processes adverse event information received by the Drug Safety and Pharmacovigilance department and assists in the preparation of internal and external reports
BS/BA degree in a health related or biological science related field and 5 years of experience, or
Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
Experience with preparation of investigational and post-marketing regulatory reports
Proficiency in standard desktop software programs (Word, Excel, Outlook)
Experience using ARISg or other safety database applications
Experience using MedDRA

Drug Safety Associate Resume Examples & Samples

Determining the category of information received i.e. whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines
Creating/generating AE/Product Complaint forms in the Product Complaint System
Keeping track of the Product Quality Complaints
Performing clear and accurate data capture of cases (including serious and non-serious cases from spontaneous and clinical trials origin, literature and E2B cases, as applicable) and appropriate medical assessment (including company causality and assessment of expectedness) of cases in accordance with client conventions/guidelines and Standard Operating Procedures
Reviewing ancillary documentation accompanying the reports and identifying the relevant information for processing and electronic capture in the applicable database
Maintaining an excellent knowledge of case processing conventions and guidelines, client’s procedures and international drug safety regulations
Maintaining a good working knowledge of the AE safety profile of assigned products and labeling documents
Ensuring MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”, where applicable
Interacting with internal or external contacts to resolve issues related to the processing of cases and PQCs
Performing triage of literature abstracts and/or full articles for validity, if required
Performing single case creation/initiation in the safety database, if required
Identifying areas of concern within the team and raising the issues with the Team Lead
Science/Medicine degree: The minimum qualification required would be a University degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.)
A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in hospital based environment, would be an advantage
Fluency in written and spoken English, Japanese, Chinese

Drug Safety Associate, Case Processing Resume Examples & Samples

Mentoring of other DSAs or staff, as identified
Maintains compliance with company guidelines and HR Policies
A degree within the Healthcare profession is required (RN, RPh, PharmD, BS, PhD, or other related scientific degree/qualification)
A minimum of 2 years related experience is required
Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas
Case processing experience is desired
Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
Understanding of medical terminology and ability to summarize medical information is preferred
Ability to follow guidelines and procedural documents (experience of working with SOPs etc.) is preferred
Familiarity with safety systems is preferred
Knowledge or experience with Excel, PowerPoint, Visio is preferredDrug & Product Safety Operations

Drug Safety Associate Resume Examples & Samples

Manages project in a timely manner in adherence with ICON’s SOP’s, ICH, GCP and appropriate regulation and liaise with other departments as necessary
Delivers projects in accordance with the contract, timelines and study budget
Identifies out of scope activities and initiates budget change orders and contract amendments
Attends and presents at Investigator Meetings, Client Kick-Off Meetings, and other client meetings
Ensures all necessary study specific training is provided to study team to improve performance and knowledge. Provides coaching / mentoring as necessary
Develops and maintains all trial documentation (ie Charter, Procedure Manual, Site Manual, Adjudication Forms, Communication Plan, System Requirement Specifications, Data Transfer Specifications, and Committee Training Manual)
Performs user acceptance testing of electronic endpoint adjudication system
Performs data reconciliation
Serves as the primary study contact for client and internal and external study teams
Prepares meeting agenda and facilitates the completion and distribution of meeting minutes
Conducts project/system specific training to committee members
Provides feedback to senior management on project status, metrics, client satisfaction and staffing issues
Participates in bid defense and new proposal review activities as necessary
Participates in internal, client, and regulatory audits
EU: prior relevant clinical research industry experience
Basic knowledge of applicable global, regional, local clinical research regulatory requirements; ie Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, standard operating procedures (SOPs), or the ability and willingness to gain this knowledge
Highly developed problem solving skills
Knowledge of medical terminology
Excellent organizational, time management and problem-solving skills
Strong sense of responsibility and dedication
Attentiveness to detail and accuracy; ability to maintain quality standards
Proven ability to multi-task, manage competing priorities and timelines
Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employees’ location, the employee may be required to possess a valid Drivers license
Bachelors’ Degree or local equivalent in medicine or science
Licensed nursing professional or similar medical/scientific certification

Senior Drug Safety Associate Resume Examples & Samples

Process timely SAEs reports of FivePrime investigational products in accordance with all applicable regulations, guidelines. Regulatory Authorities and cross-reporting to pharmaceutical partner(s)
Ensure all safety information is handled in a manner consistent with departmental standard operating procedures as well as federal and international regulations
Liaise with Clinical Science to ensure that appropriate medical review and assessment is provided for assigned case reports
Assist in the safety management activities for Five Prime Sponsored Clinical Trials
Participate in development, implementation and maintenance of quality systems for all Drug Safety activities, encompassing processes, procedures, compliance and metrics
Participate in the preparation of aggregate safety reports such as DSUR and IND Annual Reports, to regulatory authorities
Maintain regulatory and department compliance by ensuring timely completion of reports and facilitating submissions of reportable cases to regulatory agencies, study investigators, and licensing partners
Assist with periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies
Participate in cross-functional project teams representing the Drug Safety department
Assist in monitoring industry best practices, and changes in global safety regulations and guidelines, recommend changes/ upgrades to existing departmental policies, SOPs and systems
Draft drug safety documents, such as Safety Management Plans for clinical studies, and development of various forms as required, such as SAE Reporting Forms, Pregnancy Reporting Forms

Drug Safety Associate / Specialist Resume Examples & Samples

Develop project specific safety procedures, workflows and templates
Perform project specific safety database setup, develop data entry guidelines, and perform user acceptance testing
Perform registration with relevant authorities for electronic reporting on behalf of sponsor
Sound knowledge of drug safety and the drug development process
Good presentation skills
Ability to work collaboratively and effectively in a team environment
Client focused approach to work

Drug Safety Associate Resume Examples & Samples

Receive and process all reports of adverse drug experiences in accordance with established Local Health Authority requirements, Local Operating Company and Global Medical Safety SOPs
Maintain a central repository of records of locally reported adverse drug experience reports
Conduct regular reconciliation with health authorities, medical information (spontaneous), medical research (local trials), health economics and marketing (solicited activities) departments, in line with SOPs
Liaise with Global Clinical Operations and Regulatory Affairs to co-ordinate data collection and responses within specified timelines
Participate in the review of safety sections of local clinical studies, health economic and marketing proposals for compliance with GMS and regulatory safety reporting requirements; document review of all proposals
A degree in pharmacy, medical or life science
Pharmaceutical industry experience in drug safety would be desirable
Ability to critically appraise medical literature
Competence in MS Office Applications (MS Word, Outlook, Access, Excel)
A track record of success with excellent communication skills
A collaborative, results-orientated style and approach
High integrity and work ethics, in line with our company's core values

Medical Information / Drug Safety Associate Resume Examples & Samples

Minimum of 1 years industry experience in MI or PV
Ability to understand technical, scientific, and medical information
Ability to search, interrogate and interpret results of database searches
Ability to work independently on routine and new assignments
Organisational skills, including the ability to prioritise

Drug Safety Associate Resume Examples & Samples

Be with the experience in PV and Safety Services at least 1 years
Knowledge on Argus on any other safety database
Project management or Lead DSA assignment is a plus

Drug Safety Associate Resume Examples & Samples

Search Pharmacovigilance inbox for relative source records for legacy SAE case reports
Review source documentation for SAEs reported to Karyopharm from Clinical Trials, ISTs, and Compassionate Use
Upload source documents to ARGUS safety database
Write SAE case narratives for applicable reports
Perform peer quality reviews for data entry and SAE narratives within ARGUS
Collaborate with PV MD for collating SAE queries as applicable per SAE case
Write and send SAE queries to Investigative sites, CRAs, and CTM’s utilizing Query templates and Query Activity tracking within ARGUS
Manage open cases to closure
Assist with SAE reconciliation with DM as needed
Assist with the management of SAE intake from the Pharmacovigilance Inbox, confirming receipt of SAEs with applicable reporters, triaging reports upon receipt, and logging reports on SAE and SUSAR trackers
Prior PV experience in Clinical Development
Knowledge and experience working in safety data bases (ARGUS, ARISg, etc)
Working knowledge and familiarity with medical terminology
Understanding of medical records including laboratory results and procedures
Knowledge and experience with MedDRA coding
Basic understanding of the regulations and legislation governing pharmacovigilance activities
Experience working in a GCP environment
Ability to be flexible with changing priorities and shifting focuses

Drug Safety Associate Resume Examples & Samples

Reconciliation activities with all data sources providing safety information - e.g. Specialty Pharmacies, Business Partners and Internal Stakeholders to ensure compliance
Preparation of content and delivery of training to case management end-users
Working with ARISg
Working with pharmacovigilance data using a reporting tool such as Business Objects

Senior Drug Safety Associate Resume Examples & Samples

Ability to present and share useful business information across departments and functions
Ability to anticipate and identify problems and take appropriate action to correct
Knowledge of ICH Guidelines
Knowledge of Medical Device reporting desirable
Good knowledge and understanding of industry and R&D processes and objectives
Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial

Drug Safety Associate Resume Examples & Samples

*Education/Qualifications***
Non-degree: 4-5 years of relevant experience (or 2 years of safety experience)*
Associates Degree: 3-4 years of relevant experience (or1-2 years of safety experience)*
Associate degree RN: 2-3 years relevant experience (or l-2 years of safety experience)*
BS/BA: 1-2 years of relevant experience**

Drug Safety Associate Resume Examples & Samples

Related experience with a proven understanding of pharmacovigilance
Strong knowledge of Swiss legislation & regulation
Fluency in German and English required, French knowledge is a plus

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