Director, PV Operations

Position Overview

The Director of Pharmacovigilance (PV) Operations will provide strategic and operational leadership for pharmacovigilance activities across the clinical development lifecycle, with readiness to support future post‑marketing activities. This role is responsible for ensuring compliant, efficient, and high‑quality safety operations in accordance with global regulatory requirements, while partnering closely with cross‑functional stakeholders in a fast‑paced oncology biotech environment.

This role is based in our Boston office and follows a hybrid schedule, with three in‑office days each week.

Responsibilities

• Lead and oversee all PV operational activities, including adverse event intake, case processing, quality review, and regulatory reporting.
• Ensure timely and compliant submission of expedited safety reports (e.g., SAEs, SUSARs) and support aggregate safety reporting activities (e.g., DSURs, PSURs/PBRERs).
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