Associate Director, Pv Scientist

Bilbao HR (Biogen?)

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

Job Summary

  • Serve as the lead PV Scientist for specific products, providing strategic direction and scientific oversight for safety surveillance and aggregate reports.
  • Oversee signal detection, Risk Management Plans (RMPs), and aggregate reports, while collaborating with cross-functional teams and responding to regulatory requests.
  • The role offers a competitive base salary range of $172,000.00-$237,000.00, eligibility for incentives, and a comprehensive benefits package including medical, dental, vision, and retirement plans.

Matching Summary

Serve as the lead PV Scientist for specific products, providing strategic direction and scientific oversight for safety surveillance and aggregate reports.

Salary

Base: $172,000.00-$237,000.00; Bonus/Equity: short term and long-term incentives, cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, & Life insurances, Fitness & Wellness programs, Short- and Long-Term Disability insurance, paid vacation, holidays, paid days off for Personal Significance, sick time, Paid Maternity and Parental Leave, 401(k) program with company matched contributions, 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)
  • Respond to regulatory requests
  • Global PV regulations compliance

Nice-to-have

  • Collaborative team environment
  • Distill complex data
  • Patient and public health impact
  • Pioneering spirit
  • Inclusion and belonging culture

Key Requirements

  • Minimum 10 years Pharmacovigilance experience
  • Experience in safety signal management
  • Experience in responses to health authorities
  • Aggregate safety reports writing
  • Authoring and leading safety sections for Global Filings
  • Authoring and leading EU Risk Management Plan
  • Authoring signal evaluation or analysis
  • Ability to assess resource needs

Work Rights

Not specified

Tailored Resume

Cover Letter