Regulatory Safety Lead (MD)

ProPharma Group•Raleigh, NC

13h•Hybrid

About The Position

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Requirements

MD required.
Must have previously served as Head of Pharmacovigilance / Global Drug Safety (large pharma or well‑established biotech strongly preferred).
15+ years of progressive experience in pharmacovigilance and regulatory safety within the biotechnology or pharmaceutical industry.
Deep, hands‑on experience representing organizations to the FDA and other global regulatory authorities.
Proven leadership overseeing global PV operations.
Demonstrated experience supporting late‑stage development and NDA/BLA submissions.
Track record of building, scaling, and governing fit‑for‑purpose PV processes and infrastructure in preparation for commercialization.

Responsibilities

Representing organizations to the FDA and other global regulatory authorities, including ownership of safety interactions and inspections.
Overseeing global PV operations, including case management, safety surveillance, risk management, benefit–risk assessment, compliance, and PV quality systems.
Supporting late‑stage development and NDA/BLA submissions.
Building, scaling, and governing fit‑for‑purpose PV processes and infrastructure in preparation for commercialization.