Associate Director, PV Scientist
Biogen
18 days ago
Remote friendly (Cambridge, MA)
United States
Medical Affairs
What You’ll Do
- Serve as the lead PV Scientist for a specific product or group of products (investigational and/or marketed), providing strategic direction and scientific oversight.
- Oversee signal detection and management activities, Risk Management Plans (RMPs—core and EU), and aggregate reports such as Development Safety Update Reports (DSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs).
- Lead and collaborate with Safety MD, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory colleagues.
- Respond to regulatory requests and support regulatory filing activities related to product safety.
- For line management roles, manage, mentor, and train a team that may include associate PV Scientists, PV Scientists, and Senior PV Scientists.
- Ensure strict compliance with global PV regulations and drive process improvements.
- Lead and coordinate key departmental initiatives to advance the Safety Surveillance and Aggregate Reports group’s strategic goals.
Required Skills
- Minimum 10 years Pharmacovigilance experience, including safety signal management, responses to health authorities, and aggregate safety reporting in clinical trial and post-marketing settings.
- Experience authoring and leading safety sections for Global Filings (e.g., US NDA, EU MAA), including authoring and leading the EU Risk Management Plan.
- Experience authoring signal evaluation/analysis, safety RMPs (core and EU), and aggregate reports (DSURs, PBRERs).
- Ability to understand, interpret, analyze, and clearly present scientific/medical data verbally and in writing.
- Strong organizational skills with independent prioritization and resource assessment.
- Represent processes in cross-Safety and cross-functional forums.
Benefits
- Base compensation range: $172,000.00–$237,000.00
- Medical, Dental, Vision, and Life insurances; fitness reimbursement; short- and long-term disability; 15 days paid vacation plus end-of-year shutdown; paid holidays; sick time; paid maternity and parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.
Hybrid: Cambridge, MA office
- Serve as the lead PV Scientist for a specific product or group of products (investigational and/or marketed), providing strategic direction and scientific oversight.
- Oversee signal detection and management activities, Risk Management Plans (RMPs—core and EU), and aggregate reports such as Development Safety Update Reports (DSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs).
- Lead and collaborate with Safety MD, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory colleagues.
- Respond to regulatory requests and support regulatory filing activities related to product safety.
- For line management roles, manage, mentor, and train a team that may include associate PV Scientists, PV Scientists, and Senior PV Scientists.
- Ensure strict compliance with global PV regulations and drive process improvements.
- Lead and coordinate key departmental initiatives to advance the Safety Surveillance and Aggregate Reports group’s strategic goals.
Required Skills
- Minimum 10 years Pharmacovigilance experience, including safety signal management, responses to health authorities, and aggregate safety reporting in clinical trial and post-marketing settings.
- Experience authoring and leading safety sections for Global Filings (e.g., US NDA, EU MAA), including authoring and leading the EU Risk Management Plan.
- Experience authoring signal evaluation/analysis, safety RMPs (core and EU), and aggregate reports (DSURs, PBRERs).
- Ability to understand, interpret, analyze, and clearly present scientific/medical data verbally and in writing.
- Strong organizational skills with independent prioritization and resource assessment.
- Represent processes in cross-Safety and cross-functional forums.
Benefits
- Base compensation range: $172,000.00–$237,000.00
- Medical, Dental, Vision, and Life insurances; fitness reimbursement; short- and long-term disability; 15 days paid vacation plus end-of-year shutdown; paid holidays; sick time; paid maternity and parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.
Hybrid: Cambridge, MA office