Senior Pharmacovigilance Scientist — Safety Signal Lead

Biogen, Inc.; Maidenhead; On-site; GBP 70,000 - 100,000; Full time

Job summary

Biogen is seeking a Senior Pharmacovigilance Scientist to lead safety signal management, PSUR/DSUR oversight, and regulatory safety responses. You will guide cross-functional teams, review medical literature, and support clinical trial PV activities to maintain global safety standards.

This role emphasizes leadership, data interpretation, and mentoring staff. You will collaborate with Global Safety Officers and Safety MDs across programs to ensure compliant safety programs and timely outputs for

Qualifications

• PhD, MPH, NP, PharmD or equivalent advanced degree required.
• Significant pharmacovigilance experience with aggregate reports and signal management.
• Ability to analyze and present scientific data clearly.
• Strong knowledge of pharmacovigilance, drug development, and safety regulations.
• Proficiency with Excel/PowerPoint/Word and safety databases.

Responsibilities

• Lead signal management and safety signal detection for assigned products.
• Oversee safety literature reviews and aggregate report management (PSURs, DSURs, RMPs).
• Prepare clear responses to safety questions from regulators.
• Collaborate with Global Safety Officers and Safety MDs on trials and committee management.
• Mentor staff and manage safety data analyses requests.

Skills

PhD/MPH/NP/PharmD

Pharmacovigilance experience

Data interpretation/presentation

Drug development knowledge

Leadership & collaboration

Safety data analysis basics (Excel/OB)

Education

Advanced degree (PhD/MPH/NP/PharmD)

Tools

Microsoft Office

Business Objects

Safety database systems

Job description

Biogen is seeking a Senior Pharmacovigilance Scientist to lead safety signal management, PSUR/DSUR oversight, and regulatory safety responses. You will guide cross-functional teams, review medical literature, and support clinical trial PV activities to maintain global safety standards.

This role emphasizes leadership, data interpretation, and mentoring staff. You will collaborate with Global Safety Officers and Safety MDs across programs to ensure compliant safety programs and timely outputs for