Associate Director, Pharmacovigilance Scientist

Biogen

Cambridge, MA, United States
$172,000.00-$237,000.00; bonus/equity: cash bonus ...
Hybrid
Safety surveillance and aggregate reports
Signal detection and management
Risk management plans (rmps)
Serve as the lead PV Scientist for a specific product or group of products, providing strategic direction and scientific oversight

Job Summary

  • Serve as the lead PV Scientist for a specific product or group of products, providing strategic direction and scientific oversight.
  • Demonstrate leadership and interact collaboratively and effectively in a team environment including Safety MD, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory colleagues.
  • Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being.

Matching Summary

Serve as the lead PV Scientist for a specific product or group of products, providing strategic direction and scientific oversight.

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 vacation, company holidays, paid days off for Personal Significance, sick time, Paid Maternity and Parental Leave, 401(k) program with company match, Employee stock purchase plan, Tuition reimbursement

Skills & Requirements

Must-have

  • Safety Surveillance and Aggregate Reports
  • signal detection and management
  • Risk Management Plans (RMPs)
  • aggregate reports (DSURs, PBRERs)
  • regulatory requests and filing support

Nice-to-have

  • collaborative and high-performing team
  • distill complex data into actionable insights
  • exceptional organization and time-management skills
  • contributions make a significant impact

Key Requirements

  • Minimum 10 years Pharmacovigilance experience
  • experience in safety signal management
  • responses to health authorities
  • aggregate safety reports writing
  • authoring and leading safety sections for European Marketing Authorization application filing
  • authoring and leading the EU Risk Management Plan
  • authoring signal evaluation or analysis
  • understand, interpret, analyze, and clearly present scientific and medical data

Work Rights

Not specified

Tailored Resume

Cover Letter