Associate Director, Pharmacovigilance Scientist
$162,000–$223,000 year
Remote · United States or Waltham, Massachusetts, United States
Job Summary
Lead PV Scientist role as Associate Director responsible for safety data analyses for assigned products, including signal detection, aggregate reports (DSURs, PADERs, PBRERs), risk management plans, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA). Acts as SME for PV Sciences, mentors junior staff, drives process improvements, and contributes to audits/inspections and regulatory filings (IB/RSIs, CSRs, DMC materials, RMPs). Collaborates with Safety Physician and cross-functional stakeholders, managing and/or contributing to safety governance materials and safety-related regulatory queries. Requires advanced PV expertise, strong communication, and the ability to lead strategic initiatives and mentorship.
Required Qualifications
- Minimum 5-6 years PV experience, including 3-4 years in a PV Scientist or similar role
- Advanced degree (PharmD, RN, MD, PhD, MPH, NP, MS)
- Demonstrated experience in analysis and interpretation of medical and scientific data
- Experience leading signal management activities and preparation/authoring of aggregate reports
- Experience preparing regulatory safety documents, including NDAs/MAAs and RMPs
- Experience serving as SME in audits and inspections
- Excellent oral and written communication skills
- Detail-oriented with ability to prioritize tasks and work independently
- Expert knowledge of pharmacovigilance and drug development and applicable regulations
- Experience with PV databases and coding dictionaries
- Proficiency with Microsoft Office Suite and Argus Safety systems
- Willingness to work in a fast-paced, cross-functional environment
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