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

• Director

Employment type

• Fulltime

Job function

• Strategy/Planning, Production, and Science

Industries

• Pharmaceutical Manufacturing, Biotechnology Research, and Staffing and Recruiting

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