Medical Director, Drug Safety

Responsibilities

• Serve as the medical safety lead for assigned products, providing clinical and pharmacovigilance expertise to safety strategy and activities.
• Lead aggregate safety data analysis for signal detection, signal evaluation, and risk characterization.
• Conduct medical review and interpretation of safety data, contributing to benefit–risk assessments.
• Monitor emerging safety signals and proactively address potential safety risks through appropriate internal and external communication.
• Contribute to safety responses to regulatory authorities and participate in regulatory interactions.
• Provide clinical leadership during inspections and audits related to safety and risk management.
• Author and review regulatory safety documents, including: DSURs, safety sections of INDs, and regulatory briefing books.
• Provide clinical input into safety aspects of clinical trial protocols, informed consent forms, and investigator brochures.
• Collaborate with clinical development, regulatory affairs, medical affairs, and other stakeholders to ensure a consistent global safety strategy.
• Governance and Cross-Functional Collaboration: Serve on safety governance committees, supporting strategic decision-making for risk mitigation and benefit–risk evaluation.

Requirements

• Medical degree (MD) is required.
• Clinical experience preferred.
• 10+ years of experience in pharmacovigilance/ drug safety within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in aggregate safety analysis and benefit–risk evaluation.
• Strong knowledge of global pharmacovigiveance regulations and guidance (ICH, FDA, EMA, MHRA).
• Experience supporting early and late-stage clinical development, regulatory submissions, and product launch.
• Experience in post-marketing safety surveillance and risk management.
• Experience interacting with global health authorities on safety matters.
• Familiarity with signal detection and safety surveillance tools and databases.
• Strong communication, collaboration, and cross-functional leadership skills.
• Able to interpret complex clinical and safety data and translate insights into regulatory and business strategy.
• Able to work effectively and collaboratively in a fast-paced, growing organization.