Job Description
Director, Drug Safety & Pharmacovigilance
Join a leading global pharmaceutical organization committed to patient safety and innovative therapies. This Director-level role offers the opportunity to lead pharmacovigilance activities across both clinical and marketed products within a collaborative, hybrid work environment.
Role Overview
As Director, Pharmacovigilance , you will provide strategic and operational leadership for safety activities, ensuring compliance with regulatory requirements and highquality safety evaluations. The role includes a focus on US regulatory expectations, including FDA reporting and postmarketing surveillance, while collaborating with global teams.
Key Responsibilities
- Lead pharmacovigilance activities across clinical and postmarketing products, ensuring compliance with applicable regulations, including US requirements.
- Perform and oversee medical review of ICSRs, including seriousness, expectedness, causality, and MedDRA coding.
- Manage followup of highpriority cases and vendor case processing.
- Support safety surveillance, signal detection, and Risk Management Plan maintenance.
- Prepare and review regulatory safety reports, including USspecific reports (e.g., PADERs, IND Annual Reports, 15Day Expedited Reports).
- Contribute to clinical and regulatory documents, including protocols, IBs, CSRs, and labeling updates.
- Serve as a key safety advisor within crossfunctional teams and Safety Management Team meetings.
Candidate Requirements
- Advanced healthscience degree (MD, PharmD, or equivalent preferred).
- 812+ years of pharmacovigilance or medical safety experience in pharma/biotech.
- Knowledge of US clinical and postmarketing PV regulations and FDA requirements.
- Experience beyond routine case processing across clinical and postmarketing safety.
- Proven ability to lead crossfunctional teams and influence decisionmaking.
- Strong communication skills and experience collaborating with global colleagues.
- Comfortable with hybrid work, onsite in Greater Boston at least 2 days per week.
Whats on Offer
- Permanent, fulltime role with competitive salary and benefits.
- Hybrid work flexibility with regular onsite collaboration.
- Work alongside an incredible mentor & manager; a fasttrack for growth potential.
- Lead pharmacovigilance strategy within a global safety framework.
- Exposure to diverse products, regulatory submissions, and crossfunctional teams.
- Make a tangible impact on patient safety and regulatory compliance.
Seniority level
Employment type
Job function
- Strategy/Planning, Production, and Science
Industries
- Pharmaceutical Manufacturing, Biotechnology Research, and Staffing and Recruiting
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Job Tags
Permanent employment, Full time, 2 days per week,