Director, Pharmacovigilance

Director, Pharmacovigilance – Humacyte

Department: Regulatory Affairs
Location: Durham, NC;
Partially Remote
Company: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease.

Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation.

For more information, visit

Job Summary: The Director of Pharmacovigilance (PV) is responsible for leading global drug safety activities and ensuring compliance with regulatory requirements for adverse event (AE) reporting. This position oversees the integrity of safety data across clinical and post‑marketing programs, ensuring timely, accurate submissions to global health authorities and effective signal detection, risk management, and safety evaluation processes. The Director provides strategic leadership for PV operations, collaborates cross‑functionally with Regulatory Affairs, Clinical Development, and Data Management teams, and drives continuous improvement of PV systems and procedures to uphold patient safety and regulatory excellence.

This role also contributes to medical safety strategy development and supports regulatory submissions, including BLAs and clinical study reports. It is a full‑time position that may be performed remotely from any location within the continental U.S. and reports to the Head of Pharmacovigilance and Medical Monitoring.
Note: This position requires a Doctor of Medicine (MD).

Essential Functions:

• Provide PV medical and technical support to one or more clinical project teams to ensure the successful design and execution of Clinical Development Plans.
• Oversee vendors performing medical review of individual case safety reports (ICSRs) and aggregate safety reports on behalf of the company. Author analyses of similar events (AOSE) and provide medical review and comments for ICASRs.
• Partner with CROs to ensure safety reporting, tracking, and documentation meet internal SOPs and global regulatory requirements.
• Lead global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting.
• Drive inspection readiness and lead interactions with global health authorities for safety‑related audits and inquiries.
• Contribute to the preparation and submission of periodic safety reports (e.g., PBRERs, DSURs, PADERs, Annual Reports, Investigator’s Brochures) within required timelines.
• Contribute to the safety sections of clinical documents such as study protocols, clinical study reports, Investigator’s Brochures, and regulatory submissions.
• Support development, implementation, and evaluation of Risk Management Plans (RMPs) and post‑marketing safety studies.
• Provide medical support for clinical trials, including review of safety queries, eligibility assessments, lab findings, ECGs, etc.
• Collaborate with Data Management and PV vendors to reconcile adverse events between clinical and safety databases. Collaborate in data cleaning and review of Tables, Listings, and Figures (TLFs) before database lock.
• Work with the Head of Safety to develop medical safety strategies and achieve PV Medical Safety objectives and support regulatory submissions, including BLAs and clinical…