Director, Drug Safety & Pharmacovigilance (Boston) Job at i-Pharm Consulting, Boston, MA

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  • i-Pharm Consulting
  • Boston, MA

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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Job Tags

Permanent employment, Full time, 2 days per week,

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