Associate Director, Pharmacovigilance Scientist

Summary

Join Biogen's Safety Surveillance and Aggregate Reports (SSA) team as an Associate Director, Pharmacovigilance Scientist. You will manage processes for Aggregate Reports (PSURs, DSURs, PADERs, etc.), serving as a subject matter expert on global safety requirements. Lead the production of Aggregate Safety Reports, respond to health authority inquiries, and independently lead process improvement initiatives. Collaborate with vendors and internal teams to ensure high-quality reports. This role involves mentoring PV Scientist staff and overseeing the Aggregate Reports Master Schedule. The ideal candidate possesses strong analytical skills, thrives in collaborative environments, and enjoys working with medical scientific data.

Requirements

• Bachelor’s Degree in biologic or natural science OR Advanced degree (MSc, PhD, MPH, PharmD, etc.)
• Minimum 8-10 years Pharmacovigilance experience, including experience in aggregate safety reports writing, responses to health authorities, and safety signal management in both clinical trial setting and post-marketing

Responsibilities

• Lead independently and collaboratively all aspects of substantive projects including authoring aggregate safety reports and responses to regulatory agency requests
• Serve as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as in-depth Aggregate Reports knowledge. Serve as example for behaviors that lead to high quality outputs
• Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview
• Identify process non-compliance, gaps or inefficiencies and lead initiatives for process improvement, implements and maintains processes. Manage corrective actions when non-compliances are identified
• Oversee and mentor PV Scientist staff

Preferred Qualifications

• You are curious and have an analytical mind
• You are enthusiastic and thrive working in a highly collaborative team
• You enjoy working with medical scientific data sets to provide well written conclusions
• You do not shy away from providing suggestions for process improvements
• You enjoy guiding stakeholders in current processes or legislative requirements