Director, Drug Safety & Pharmacovigilance

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 high‑quality safety evaluations. The role includes a focus on US regulatory expectations, including FDA reporting and post‑marketing surveillance, while collaborating with global teams.

Key Responsibilities

Lead pharmacovigilance activities across clinical and post‑marketing products, ensuring compliance with applicable regulations, including US requirements.

Perform and oversee medical review of ICSR’s, including seriousness, expectedness, causality, and MedDRA coding.

Manage follow‑up of high‑priority cases and vendor case processing.

Support safety surveillance, signal detection, and Risk Management Plan maintenance.

Prepare and review regulatory safety reports, including US‑specific reports (e.g., PADERs, IND Annual Reports, 15‑Day Expedited Reports).

Contribute to clinical and regulatory documents, including protocols, IBs, CSRs, and labeling updates.

Serve as a key safety advisor within cross‑functional teams and Safety Management Team meetings.

Candidate Requirements

Advanced health‑science degree (MD, PharmD, or equivalent preferred).

8–12+ years of pharmacovigilance or medical safety experience in pharma / biotech.

Knowledge of US clinical and post‑marketing PV regulations and FDA requirements.

Experience beyond routine case processing across clinical and post‑marketing safety.

Proven ability to lead cross‑functional teams and influence decision‑making.

Strong communication skills and experience collaborating with global colleagues.

Comfortable with hybrid work, onsite in Greater Boston at least 2 days per week.

What’s on Offer

Permanent, full‑time role with competitive salary and benefits.

Hybrid work flexibility with regular onsite collaboration.

Work alongside an incredible mentor & manager; a fast‑track for growth potential.

Lead pharmacovigilance strategy within a global safety framework.

Exposure to diverse products, regulatory submissions, and cross‑functional teams.

Make a tangible impact on patient safety and regulatory compliance.

Seniority level

Director

Employment type

Full‑time

Job function

Strategy / Planning, Production, and Science

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Staffing and Recruiting

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