Senior Pharmacovigilance (PV) Scientist

As a Senior Pharmacovigilance (PV) Scientist, you will play a pivotal role as a product lead within the Safety team, overseeing and spearheading critical PV activities. Your responsibilities encompass managing the safety signal process, authoring aggregate reports like PSURs and DSURs, and addressing safety inquiries from both internal and external stakeholders. You'll delve into medical and scientific literature to extract vital safety information while supporting Clinical Trial PV medical activities. Collaborating with the Associate Director, you will also hire, train, and mentor staff dedicated to product-specific tasks. Your role as a Subject Matter Expert ensures compliance with global safety regulations and guidelines, fostering data analysis and product information sharing across cross-functional teams. This position is vital for maintaining the integrity and continuity of clinical trials and marketed products, ensuring they meet regulatory standards globally. This is hybrid role requiring a minimum of 50% on site office attendance per week in Maidenhead.

• Lead the signal management process, including signal detection, documentation, and safety risk decisions for assigned products.
• Author signal evaluation reports and manage literature review for safety information.
• Respond to safety questions from regulatory authorities and lead Aggregate Report management.
• Finalize aggregate safety reports such as PSURs, DSURs, REMS, and RMPs for assigned products.
• Collaborate with Global Safety Officers and Safety MDs on investigational programs, including clinical trial activities and safety committee management.
• Manage data analysis, signal detection, and product activities as assigned.

• You are a passionate, resourceful, and motivated PV Scientist with strong problem-solving capabilities who brings enthusiasm to the role.
• You excel in understanding and interpreting complex scientific data, presenting it clearly both verbally and in writing.
• Your ability to collaborate effectively in a team environment and apply clinical judgment makes you an ideal fit for this position.
• You thrive in a dynamic setting where prioritization and organizational skills are key.

• Bachelor's Degree in biologic or natural science, or health care discipline; or Advanced degree (PhD, MPH, NP, PharmD, etc.) required.
• Significant and proven Pharmacovigilance experience, including aggregate safety reports and safety signal management.
• Experience leading and conducting projects related to signaling and regulatory agency requests.
• Ability to interpret, analyze, and present scientific and medical data clearly.
• Strong foundation in Pharmacovigilance and drug development, including knowledge of safety regulations.
• Proficiency in common data processing software (Excel, PowerPoint, Microsoft Word).
• Leadership skills and collaborative interaction in team environments, internally and externally.
• Strong organizational skills with the ability to prioritize independently.

• Knowledge of common safety database systems.
• Experience in interacting with cross-functional teams such as Clinical Development and Regulatory.

Management

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.

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.