PURPOSE OF THE FUNCTION
The Safety Risk Management Lead provides safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development). S/he will perform ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.
ROLES AND RESPONSIBILITIES
1. Lead safety signal management activities including data preparations and presentations.
2. Assist GPS GSLs in their assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders internally.
3. Prepare data for and actively participate in safety governance and risk management processes including safety management teams (SMT) and benefit-risk committees (BRC).
4. Effectively lead, oversee and participate in the planning, preparation and review of periodic reports (DSUR, PSUR, PADER).
5. Participate in the presentation and analysis of safety data from on-going and completed clinical trials.
6. Review and provide safety input, as needed, for key study-related documents, e.g., Investigator’s Brochure (IB), Informed Consent Form (ICF), Independent Data Monitoring Committee (IDMC) Charter.
7. Participate in protocol development and review, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans, as needed.
8. Participate in departmental development activities including SOP and Work Instructions development.
9. Perform other activities as needed to assist with departmental activities.
SKILLS AND COMPETENCIES
10. Knowledge of pharmacovigilance as applies to safety signal management, safety data review in clinical and post-marketing settings
11. Knowledge of relevant global pharmacovigilance regulations and guidelines
12. Ability to prepare and/or review high quality safety documents, including periodic aggregate safety reports, signal evaluation report, or risk management plans.
13. Ability to communicate complex issues effectively
14. Ability to influence and collaborate with multidisciplinary teams
15. Ability to prioritize and plan proactively
16. Excellent analytical and problem-solving skills, with sound autonomy and applied judgment
17. Experience with MedDRA, WHO Drug Dictionary
18. Understanding of the principles of databases, querying data sources as well as developing and applying search strategies
19. Relevant computer skills including proficiency with Microsoft Office
20. Fluency in written and spoken English
EDUCATION, EXPERIENCE AND QUALIFICATIONS
21. Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life sciences or technical fields (Ph. D. or M.D a plus)
22. Minimum of 7-10 years of relevant pharmaceutical/biotech industry or healthcare experience
23. Pharmacovigilance/safety risk management experience is strongly preferred
For applicants in the United States: The annual base salary hiring range for this position is $164,000.00 - $246,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.
This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.