Sr. Pharmacovigilance (PV) Scientist

Company Description

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry, and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

Job Description

About This Role

Senior PV Scientist serves as a product lead for Pharmacovigilance activities within Safety. The Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. The Senior PV Scientist, along with the Associate Director is responsible for hiring, training, mentoring and managing staff within their assigned products. The Senior PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information. 

What You’ll Do

• Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
• Leads process for responding to safety questions from regulatory authorities.
• Leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Plans (REMS), and Risk Management Plans (RMPs).
• Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.

Who You Are

You are passionate about the safety of those taking our medications and able to understand, interpret, analyze, and clearly present the data in verbal and written format. You enjoy working in teams and have strong organizational and time-management skills.

Qualifications

Required Skills

• Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management experience
• Bachelor’s Degree in biologic or natural science; or health case discipline. Advanced degree (PhD, MPH, NP, PharmD, etc.) required

Additional Information

All your information will be kept confidential according to EEO guidelines.