Pharmacovigilance Scientist

About This Role

PV Scientists are responsible for assigned tasks for designated products or product groups. Reporting to a Sr. PV Scientist or above, the PV Scientist will serve either as a lead PV Scientist or supporting PV Scientist, depending on his/her assigned product or product groups. Irrespective, the PV Scientist is a critical team member whose responsibilities include performing signal management activities, authoring safety evaluations, contributing to aggregate report planning / authoring, responding to ad hoc regulatory responses, conducting safety literature reviews, and serving on clinical trial safety teams. The PV Scientist, with oversight from their manager, will serve as a Subject Matter Expert for the Global Safety and cross-functional team on relevant global safety regulations and guidelines, data output and analyses, and product information. This position is Hybrid based out of our Cambridge, MA office

What You'll Do

• Collaborates on the preparation and authoring of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).
• Facilitates signal management process for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with the Global Safety Officer, Safety physicians and Sr. PV Scientist / AD, performs routine signaling activities including evaluation of safety data for new signals as part of ongoing pharmacovigilance activities. May include authoring signal evaluation reports, or sections of signal evaluation reports. Conducts literature review for safety information and interacts with other groups to obtain necessary data (i.e., Epidemiology, SAE data).
• With Sr. PV Scientist / AD oversight, collaborates with Clinical Trial physicians and Global Safety Officers on assigned investigational programs including protocol review, safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.
• In collaboration with Sr. PV Scientist / AD, coordinates and authors responses to safety questions from regulatory authorities for assigned products.
• Contributes to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
• Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
• Interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical, Clinical Operations, and Regulatory), as well as with external colleagues
• Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff.
• Applies clinical judgment to interpret case information.
• Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.

Who You Are

You are deeply invested in ensuring the utmost safety for patients involved in clinical trials or using our 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.

Required Skills

• Bachelor's Degree in biologic or natural science; or health case discipline.
• Minimum 5 years industry experience, with a minimum of 3 years of PV experience

Preferred Skills

• Advanced Degree preferred (PhD, MPH, NP, PharmD, etc.)

Job Level: Management

Additional Information

The base compensation range for this role is: $122,000.00-$163,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

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.

Client-provided location(s): Cambridge, MA

Job ID: Biogen-REQ22699

Employment Type: FULL_TIME

Posted: 2026-02-26T19:01:26