Serve as the lead PV Scientist for specific products, providing strategic direction and scientific oversight for signal detection, RMPs, and aggregate reports
Job Summary
Serve as the lead PV Scientist for specific products, providing strategic direction and scientific oversight for signal detection, RMPs, and aggregate reports.
Collaborate effectively with cross-functional teams including Clinical Development, Medical Affairs, and Regulatory colleagues to ensure product safety and respond to regulatory inquiries.
Biogen offers a competitive compensation package including base salary, short-term and long-term incentives, and a comprehensive benefits package supporting employee well-being.
Matching Summary
Serve as the lead PV Scientist for specific products, providing strategic direction and scientific oversight for signal detection, RMPs, and aggregate reports.
Salary
$172,000.00-$237,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurances, Fitness & Wellness programs, Disability insurance, Paid time off, Holidays, 401(k) with match, ESPP, Tuition reimbursement
Skills & Requirements
Must-have
Signal detection and management
Risk Management Plans
Aggregate safety reports writing
Respond to regulatory requests
Scientific and medical data analysis
Nice-to-have
Collaborative team environment
Patient safety focus
Pioneering spirit
Inclusion and belonging culture
Key Requirements
Minimum 10 years Pharmacovigilance experience
Experience in safety signal management
Experience in responses to health authorities
Experience in aggregate safety reports writing
Experience authoring safety sections for EU MAA filing