Safety Scientist Job Description

Safety Scientist Job Description

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Safety scientist provides critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.

Safety Scientist Duties & Responsibilities

To write an effective safety scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included safety scientist job description templates that you can modify and use.

Sample responsibilities for this position include:

Ensure the accurate, prompt, and consistent coding of adverse event data and drugs into the Global Safety Database, coding of terms (MedDRA, WHO Drug)
Ensure that the statistical procedures are in accordance with Good Clinical, Epidemiological, and Pharmacovigilance Practices (GCP, GEP, GVP), other guidances and regulatory requirements for safety reporting
Supports the Product Safety Team (PST)
Supports the preparation and maintenance of safety sections of the Clinical Protocols, Clinical Study Reports the Company Core Data Sheet and Risk Management Plan
Provide scientific and technical leadership to support discovery and development project teams
Design and/or monitor non-GLP and GLP toxicology studies to support toxicological characterization of molecules and to support the project plans and development
Maintain up to date knowledge related to technical area of expertise including areas of disease, drugs, data interpretation and integration, and regulatory and business environment
Preparation of signaling meeting presentationsin collaboration with the team
Assist in evaluation and validation of systems to support safety supporting the development teams in safety database configuration and EDC specifications
Lead project teams and assist with new hire decisions

Safety Scientist Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Safety Scientist

List any licenses or certifications required by the position: HACCP, D.A.B.T, MS, GFSI, ASCP, EIT, ICSR, FS&Q, FS, ASQ

Education for Safety Scientist

Typically a job would require a certain level of education.

Employers hiring for the safety scientist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Nursing, Medical, Life Sciences, Healthcare, Chemistry, Engineering, Pharmacy, Health, Health Care

Skills for Safety Scientist

Desired skills for safety scientist include:

EU
ICH and FDA Regulations and Guidelines both clinical and post marketing
Database management
Life Sciences Industry
Maintain patient safety
Reviewing safety-related documents and incorporating key concepts to clearly present the reported events
ICH
Vaccine and medical device reporting requirements
SOPs
US and Ex-US pharmacovigilance risk management regulations

Desired experience for safety scientist includes:

Serves as an expert on pharmacovigilance global regulations, guidelines and industry best practices
Ensures compliance with health authority regulations with regards to data collection, analysis, reporting standards and operational consistency across interventional and non-interventional trials
Collaborates with Case Management team to ensure critical or missing SAE/AE information for appropriate medical assessment is obtained and provided to PV vendor for the studies of their responsibility
Works with CROs and clinical teams to ensure design of all trials enables timely processing and global regulatory compliance for all SAEs from assigned protocols
Collaborates with Clinical Operations, Data Management, Clinical CRO and Study Teams in development of the safety related, table design, and listings for safety data from interventional/non-interventional trials and safety reporting plans (SRP)
Responsible for medical assessment of SUSARs /(SAE of special interest) for their respective studies & cross reporting to IIT/ISR investigators

Safety Scientist Examples

1

Safety Scientist Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of safety scientist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for safety scientist
  • Literature search & clinical/safety data collection for product evaluation
  • Literature review for hazard assessment of new ingredients intended to be used in consumer products
  • Assessment of fragrances and flavors used in consumer products
  • Risk assessment for formulations for cosmetic applications including ingredients classification
  • Preparation of technical justification reports for data leverage
  • Addressing and evaluating the risk of compliance issues raised by regulatory authorities & QA, and R&D
  • Handling the escalation process to get alignment from stakeholders
  • Strategy for Claim support studies
  • Assessment for Studies for Claim substantiation
  • Be a member of the Safety Science and Policy group within the Office of Consumer Medical Safety (OCMS)
Qualifications for safety scientist
  • Ensures compliance with clinical trial activities as outlined in SRP & protocol and that proper documents are in place for monitoring
  • Ensures compliance and quality are maintained and issues are escalated appropriately and resolved
  • Authors Safety Assessment Reports and other safety documents (e.g., regulatory request, Data Monitoring Committees, IBs and CRFs) in collaboration with the Global Safety Physicians
  • Performs routine signal detection & discusses the results with RMLs for assigned products and writes up the analysis results
  • Participates in GSC for topics of their expertise
  • Prepares presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making bodies
2

Safety Scientist Job Description

Job Description Example
Our growing company is looking for a safety scientist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for safety scientist
  • Should be passionate about working on cutting edge research and developing advanced analytics/informatics solutions in the field of safety analytics and surveillance
  • Lead the safety science effort to build applications and tools by applying advanced scientific algorithms and methods and translating the strategic vision of safety science into solutions and insights
  • Work closely with customers and stakeholders to turn data into critical information and knowledge that can be used to make evidence based decisions
  • Manage relationships across IT, QA and finance functional areas
  • Apply compliance/validation requirements related to GxP-regulated applications, provides documentation as necessary, and participate in compliance/validation activities as required
  • Work effectively as part of a team and solve complex or unusual problems in consideration of the potential impact
  • Lead as a Business Analyst for moderate to large projects, programs, or initiatives of varying complexity
  • Apply and leverage technology-driven analytics (e.g., natural language processing, artificial intelligence/machine learning, semantics) in advancing safety science practice
  • Serve as key analytic and safety support lead in close collaboration with the product safety physician/medical monitor
  • Responsible for signaling review and the coordination and documentation of all signal review activities with the product safety physician and product complaint staff
Qualifications for safety scientist
  • Experience in safety data analysis and writing study related aggregate reports and safety assessments
  • Literature search, evaluation and assessment skills
  • Demonstrated commitment to quality and compliance
  • Demonstrated learning agility and ability to work independently, seeking advice as required
  • Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
  • Expertise with Microsoft Word, PowerPoint, SharePoint and Excel
3

Safety Scientist Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of safety scientist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for safety scientist
  • Coordinate ad hoc safety query or health hazard evaluation response plan for analysis in conjunction with the safety physician, Biostatistics and others as needed, including performing analysis and drafting of query responses for review and finalization
  • Key safety representation in Integrated Safety Summary reviews, which may include narrative generation, review and approval for filing related activities
  • Keeping updated on relevant regulations associated with the above activities
  • Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
  • Provide timely and accurate medical evaluation of individual and aggregated safety data from pre- and post-authorization sources
  • Contribute to signal detection from the internal safety database and FDA´s AERS database, and literature reports
  • Contribute to writing of periodic safety reports (e.g., DSUR, PBRER, pSUSAR report)
  • Contribute to response documents for Health Authority and EC/IRB requests
  • Facilitate adequate medical input in case of safety crisis/medical alert situations
  • Identifies and evaluates safety signals through assessment of individual case safety reports and aggregate data
Qualifications for safety scientist
  • Inspires confidence through influencing skills and technical ability
  • Well organized, structured, with a logic approach to issues raised
  • Able to understand and analyze clinical and medical data
  • Able to work independently and to solve complex problems and multiple projects
  • Can manage uncertainty and risks
  • PharmD, DVM required, PhD degree preferred
4

Safety Scientist Job Description

Job Description Example
Our company is hiring for a safety scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for safety scientist
  • Authors, reviews, and presents aggregate safety data including development safety update reports
  • Contributes, authors, reviews, and maintains safety sections of clinical documents including investigator’s brochure, clinical study protocols, clinical study reports, development core safety information, and development risk management plans
  • Participates as a standing member in core and sub-teams pertaining to assigned projects
  • Participates in or provides input for Independent Data Monitoring Committees (IDMC)
  • Contributes to ongoing process enhancements for safety surveillance, such as developing standard operating procedures and templates
  • Conceive, design, develop, and implement in vitro platforms to support the selection and de-risking of potential drug candidates through close interactions with discovery toxicologists, medicinal chemists, and research functions
  • Support the design, conduct, and reporting of in vitro experiments to investigate mechanisms of toxicity, species differences, human relevance or other questions to support mitigation of development-limiting liabilities for drugs and drug candidates throughout the pipeline
  • Apply data analytic and modeling approaches to assess and predict cellular phenotypic responses obtained from data-rich platforms (i.e., high content imaging and -omics data)
  • Critically evaluate new scientific techniques, platform technologies, and computational approaches to drive innovation and achieve project goals
  • Contribute to publication and/or presentation of scientific work in periodicals and external forums
Qualifications for safety scientist
  • PharmD, DVM required, PhD degree preferred or other relevant advanced degree
  • Able to give presentations to interdepartmental audiences
  • Registered Nurse, Pharmacist, or other health care professional degree
  • Ph.D or D.V.M
  • Do you have a minimum of five (5) years of industry experience in biology, chemistry, biochemistry, or related area
  • Experience in conducting, monitoring, reviewing and/or summarizing environmental toxicology and fate studies to support domestic and international registration of pharmaceuticals, specifically for subsequent environmental risk assessments
5

Safety Scientist Job Description

Job Description Example
Our growing company is looking to fill the role of safety scientist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for safety scientist
  • Develop and consult on scalable tools and methods that hazard collaboration teams will use to drive emerging issues process efficiencies
  • Have a thorough understand of existing data sources and new data sources that will best support emerging issue detection and act as SME for data scientists
  • Provide innovative thought leadership on best-in-class methods on emerging issue detection, including evaluation of automotive and non-automotive industry emerging issue methods
  • Test and drive adoption of innovative methods into the data science teams
  • Present emerging issues analysis to internal audiences by synthesizing complex data and concepts into easy-to comprehend, comprehensive, and cohesive presentations
  • Serve as a role model to other team members for issue identification, case management, and communication
  • Work with other data scientists inside and outside of hazard collaboration teams to ensure consistency in analytical approaches
  • Work with text analytics team and use appropriate text mining tools to make data analysis more efficient
  • Conduct analysis on large data sets and work on critical projects as needed
  • Collaborate with Safety, Engineering, R&D, Quality and IT stakeholders on projects
Qualifications for safety scientist
  • Experience in PK and metabolism in laboratory and food safety animals mammalian toxicology is also desired
  • 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, ), drug safety compliance, or pharmacovigilance agreements) and working in a pharmaceutical drug safety department
  • Registered Nurse, Pharmacist, or other degree in a Life Science-related field
  • 3-5 years of experience in the field of consumer product risk assessment or other relevant Toxicology experience including at least 1-2 years of clinical safety experienceToxicology Research
  • 1-2 years of experience in the field of consumer product risk assessment or other relevant Toxicology experience
  • Nursing background, life sciences degree or equivalent education

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