Associate Pharmacovigilance Scientist

About This Role

The Associate PV Scientist serves as a critical team member within the Safety Surveillance and Aggregate Report (SSA) team for products or product groups, including supporting signal management activities, contributing to aggregate report planning and authoring, responding to ad hoc regulatory responses, and conducting safety literature reviews. The role covers activities relating to marketed and/or investigational products.

• Supports signal management activities in collaboration with and oversight from PV Scientists: evaluate safety data and conduct signal management activities, update signal detection plans, contribute to or author meeting reports, presentations, and minutes, and author sections of signal evaluation reports.
• Support updates to risk management plans (RMPs).
• Collaborate with Global Safety Officers (Safety physicians).
• Represent SSA in cross‑functional meetings with other departments, such as Regulatory and Clinical Development.
• Perform ICF review, AE coding review, and other clinical‑trial safety‑related activities.
• Conduct literature review.
• General administrative tasks (request subject‑matter experts for information, schedule activities, provide information for trackers, request database outputs).
• Support aggregate report preparation in collaboration with PV Scientists, including preparation of aggregate safety reports such as PSURs and DSURs.
• Perform data review and verification, including source‑data verification and technical/scientific reviews.
• Editorial review to ensure grammatical and stylistic consistency and accuracy.
• Formatting, internal linking, and external cross‑referencing.
• Support quality checks for documents authored within the SSA team.

You are deeply invested in ensuring the utmost safety for patients involved in clinical trials or using approved treatments. With the ability to distill complex data into clear, actionable insights, you shine in a collaborative team setting. Your exceptional organization and time‑management skills enable you to thrive in a fast‑paced environment where your contributions make a significant impact on patient and public health.

• Bachelor’s degree in a biological or natural science, or a health‑care discipline.
• Minimum 3 years of industry experience with at least 3 years of pharmacovigilance experience.
• Safety case processing experience or relevant exposure to PV Scientist tasks.

• Advanced degree (PhD, MPH, NP, Pharm
  
  D, etc.).

Base compensation range: $106,000–$138,000. Base salary is determined analytically based on skills, experience, job location, and internal equity. Regular employees are eligible for short‑term and long‑term incentives, including cash bonus and equity incentive opportunities based on performance.

Benefits include:

• Medical, dental, vision, and life insurance.
• Fitness & wellness programs, including fitness reimbursement.
• Short‑ and long‑term disability insurance.
• Minimum of 15 days paid vacation and an additional shutdown time off (Dec
  26‑Dec
  31).
• Up to 12 company‑paid holidays plus 3 paid days off for personal significance.
• 80 hours sick time per calendar year.
• Paid maternity and parental leave.
• 401(k) program with company‑matched contributions.
• Employee stock purchase plan.
• Tuition reimbursement up to $10,000 per calendar year.
• Employee resource group participation.

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.