About This Role
As the Associate Director for the Safety Surveillance and Aggregate Reports group, you will play a critical part in ensuring the safety and efficacy of our products while fostering a collaborative and high‑performing team environment.
What You’ll Do
Serve as the lead PV Scientist for a specific product or group of products, providing strategic direction and scientific oversight.
Oversee signal detection and management activities, Risk Management Plans (RMPs – core and EU), and aggregate reports such as Development Safety Update Reports (DSURs) and Periodic Benefit‑Risk Evaluation Reports (PBRERs).
Delineate leadership and collaborate across Safety MD, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory colleagues.
Respond to regulatory requests and support regulatory filing activities related to product safety.
Manage, mentor, and train a team that may include associate PV Scientists, PV Scientists, and Senior PV Scientists.
Accountable for departmental processes, ensuring strict compliance with global PV regulations and driving process improvements.
Lead and coordinate key departmental initiatives to advance the strategic goals of the Safety Surveillance and Aggregate Reports group.
Who You Are
Deeply invested in ensuring the utmost safety for patients involved in clinical trials or using approved treatments.
Ability to distill complex data into clear, actionable insights and thrive in a collaborative team setting.
Exceptional organization and time‑management skills, enabling success in a fast‑paced environment.
Required Skills & Qualifications
Minimum 10 years of Pharmacovigilance experience, including safety signal management, responses to health authorities, and safety report writing in both clinical trial and post‑marketing contexts.
Experience authoring and leading safety sections for global filings (e.g., US NDA, EU MAA).
Experience authoring EU Risk Management Plans and signal evaluation or analysis reports (RMPs – core and EU).
Strong ability to understand, interpret, analyze, and communicate scientific and medical data verbally and in writing.
Excellent organizational skills with the capacity to prioritize independently with minimal supervision.
Ability to assess resource needs and adapt accordingly.
Represent and speak to processes in cross‑Safety and cross‑functional forums.
Job Level: Management.
Compensation and Benefits
Base salary range: $172,000.00–$237,000.00.
Regular employees are eligible for both short‑term and long‑term incentives, including cash bonus and equity incentive opportunities.
Medical, Dental, Vision, & Life insurances.
Fitness & Wellness programs including a fitness reimbursement.
Short‑ and Long‑Term Disability insurance.
Minimum of 15 days of paid vacation and an additional end‑of‑year shutdown time off (Dec26‑Dec31).
Up to 12 company paid holidays plus 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid Maternity and Parental Leave benefit.
401(k) program participation with company matched contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Employee Resource Groups participation.
EEO Statement
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.
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