Sr. Director, Pharmacovigilance

Genetix Biotherapeutics•Somerville, MA

3d•Hybrid

About The Position

The Senior Director of Pharmacovigilance will serve as the strategic and operational leader for the company’s pharmacovigilance function. This role combines medical oversight and PV scientist responsibilities, ensuring robust safety surveillance for marketed products and clinical programs. The ideal candidate is an MD with deep expertise in pharmacovigilance and drug safety, capable of managing both hands-on activities and team leadership in a small, fast-paced biotech environment. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office but will consider Remote. Why Join Us? Opportunity to shape the PV function in a biotech with approved products. Work on cutting-edge gene therapy treatments that make a real difference. Collaborative, mission-driven culture with room for innovation and impact.

Requirements

MD degree required; clinical experience in a relevant specialty (e.g., hematology, oncology, cell and gene therapy) preferred.
10+ years of pharmacovigilance experience, including leadership roles.
Proven experience with post-marketing PV and clinical trial safety; experience in hemoglobinopathies or cell and gene therapy preferred.
Strong knowledge of global PV regulations (FDA, EMA, ICH); experience with interaction with regulatory authorities on safety matters preferred.
Proficiency in using electronic safety databases (i.e., Argus)
Excellent analytical, communication, and decision-making skills.
Ability to thrive in a small biotech environment, balancing strategic and hands-on responsibilities.

Nice To Haves

clinical experience in a relevant specialty (e.g., hematology, oncology, cell and gene therapy)
experience in hemoglobinopathies or cell and gene therapy
experience with interaction with regulatory authorities on safety matters

Responsibilities

Serve as the Medical Director for all marketed and investigational products.
Perform medical review and assessment of adverse event reports, including seriousness, causality, and expectedness.
Author and approve aggregate safety reports (e.g., DSURs, PBRERs, SMP/RMP updates).
Provide medical input into signal detection, risk evaluation, and mitigation strategies.
Act as the primary medical contact for regulatory authorities on safety matters.
Oversee case processing activities, including timely submission of ICSRs to regulatory authorities (FAERS, EudraVigilance).
Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA).
Lead signal detection and management processes, including periodic safety reviews and safety committees.
Maintain and update PV SOPs, policies, and governance frameworks.
Manage vendor relationships for PV services and ensure quality oversight.
Collaborate with Clinical Development, Regulatory Science, Quality, and Medical Affairs to ensure integrated safety strategies.
Provide PV input into clinical trial protocols, informed consent forms, and investigator brochures.
Support labeling updates and safety sections of regulatory submissions (IND, BLA, variations).
Lead and mentor a small team of PV professionals (scientist and operational roles).
Foster a culture of compliance, scientific rigor, and continuous improvement.