Medical Director, Pharmacovigilance

We are seeking an experienced Medical Director, Pharmacovigilance (PV) to join our growing Drug Safety organization. The ideal candidate will bring deep expertise in safety surveillance, risk assessment, medical evaluation, and regulatory reporting across clinical and post-marketing environments. This individual will serve as a key medical safety leader collaborating cross-functionally to support the safe, compliant, and efficient development of our therapeutics portfolio.

Key Responsibilities

• Serve as the medical safety lead for assigned products across all phases of development, including post-marketing.
• Perform comprehensive medical evaluation of adverse event (AE) and serious adverse event (SAE) reports, including narrative review, case assessment, and clinical interpretation.
• Conduct ongoing safety surveillance, signal detection, and risk evaluation using clinical, non-clinical, and post-marketing data.
• Lead preparation and review of safety sections for regulatory submissions (INDs, CTAs, NDAs/MAAs, DSURs, PSURs/PBRERs, RMPs, etc.).
• Chair or contribute to Safety Management Teams (SMTs) and provide medical safety expertise to cross-functional teams including Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs.
• Support creation and maintenance of core safety documents such as Company Core Safety Information (CCSI), Investigator Brochures (IBs), and study protocols.
• Participate in safety governance committees and risk–benefit evaluations.
• Provide medical leadership during safety queries, inspections, audits, and regulatory authority interactions.
• Ensure compliance with global PV regulations, ICH guidelines, GCP standards, FDA/EMA requirements, and company SOPs.
• Lead internal education on safety topics, benefit‑risk principles, and PV processes.

Required Qualifications

• Medical degree (M.D. or D.O.) required; board certification in a relevant specialty (neurology, internal medicine, rheumatology, immunology, oncology, etc.) strongly preferred.
• Minimum 5–10+ years of industry experience in Pharmacovigilance, Drug Safety, or Clinical Development.
• Demonstrated expertise in AE case assessment, signal detection, and clinical interpretation of safety data.
• Experience with global safety reporting regulations and PV quality systems.
• Proven ability to lead cross-functional teams in a matrixed environment.
• Strong communication skills with the ability to present complex safety issues to internal and external stakeholders.
• Ability to manage multiple priorities in a fast-paced, evolving environment.

Preferred Qualifications

• Experience with rare disease, neuromuscular, oncology, immunology, or genetic medicine therapeutics.
• Prior involvement in interactions with global health authorities.
• Familiarity with safety databases (e.g., Argus, ArisGlobal, Veeva Safety).
• Experience supporting both clinical development and marketed products.

Key Skills

• Medical judgment & clinical decision-making
• Safety surveillance & signal detection
• Regulatory knowledge (FDA, EMA, ICH, GVP)
• Cross-functional leadership
• Strong analytical and problem-solving ability
• Excellent scientific communication
• Strategic and operational PV expertise
• High attention to detail & compliance orientation

Industry Context

This role is designed for a biotechnology or pharmaceutical company engaged in:

• Clinical-stage or commercial therapeutic development
• Rare disease, neurology, immunology, oncology, or genetic medicine
• Global multiregional clinical programs
• Fast-paced, innovation-driven environments requiring agile PV leadership

The Medical Director, Pharmacovigilance will provide medical safety leadership for assigned therapeutic programs and marketed products. This individual will be responsible for medical review of adverse event cases, benefit–risk assessment, and ongoing safety surveillance across the product lifecycle. The Medical Director will collaborate with global cross-functional teams to support clinical development, regulatory submissions, and compliance with worldwide PV requirements.

This role requires a seasoned physician with deep understanding of clinical medicine, drug safety principles, global regulatory expectations, and the ability to translate complex safety data into actionable recommendations. The Medical Director will represent the Safety organization in internal and external meetings, contribute to safety governance committees, and support regulatory agency interactions.

The ideal candidate will bring strong communication skills, scientific rigor, leadership experience, and the ability to operate effectively in a dynamic, high-growth biotech environment. This is a highly visible position with significant strategic impact on the success of our programs and the safety of patients relying on our therapies.

Seniority level

• Director

Employment type

• Full-time

Job function

• Science
• Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Wholesale Drugs and Sundries