In this hybrid medical leadership role, the physician leads clinical safety strategy and benefit-risk assessments for assigned products and development programs across the product lifecycle. The work centers on signal detection, safety surveillance, and interpretation of safety data from clinical trials, post-marketing sources, and literature. The role also partners closely with cross-functional teams to support regulatory submissions, risk management planning, and broader development decisions.
Key Responsibilities
- Lead clinical safety strategy for assigned products and programs.
- Conduct medical evaluation of safety data and benefit-risk assessments.
- Provide expert input into risk identification, characterization, and mitigation activities.
- Oversee signal detection, safety surveillance, and safety data review across clinical and post-marketing sources.
- Lead preparation and review of global safety deliverables, including DSURs, PBRERs, PADERs, and safety responses.
- Support regulatory submissions and interactions with health authorities.
- Serve as the Patient Safety representative on clinical project teams and governance forums.
- Collaborate with Clinical Development, Regulatory Affairs, Safety Science, Medical Affairs, Epidemiology, and Risk Management teams.
Required
- Medical degree (MD, MBBS, or equivalent).
- Clinical practice experience after medical qualification.
- Significant experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry.
- Strong knowledge of benefit-risk assessment, risk management, signal detection, and global pharmacovigilance regulations.
- Experience preparing or reviewing global regulatory safety documents and submissions.
- Ability to lead and influence in a matrix environment.
Preferred
- Advanced training in Pharmaceutical Medicine or a related discipline.
- Experience across multiple therapeutic areas and stages of product development.
- Experience mentoring or leading safety professionals.
Benefits & Perks
- Hybrid schedule with 3 days per week on site.
- Annual base pay range of $249,827 to $374,740 USD.
- Short-term incentive bonus opportunity.
- Eligibility for an equity-based long-term incentive program for salaried roles.
- 401(k) retirement plan.
- Paid vacation, holidays, and leaves.
- Medical, prescription drug, dental, and vision coverage.