Senior Medical Director, Pharmacovigilance

Position Overview

The Senior Medical Director of Drug Safety and Pharmacovigilance plays a pivotal role in shaping the safety strategy across the company's development pipeline. This individual will provide expert guidance on safety matters throughout the product lifecycle-from early development through post-market activities. The role involves leading risk management efforts aligned with global regulatory standards and ensuring continuous evaluation of safety data, signal detection, and benefit-risk assessments. Collaboration across departments is key to meeting project milestones with precision and quality.

Key Responsibilities

• Develop and execute safety strategies for products within the therapeutic area, ensuring alignment with clinical and commercial objectives.
• Lead signal detection and management activities, including monitoring, interpreting, and communicating safety data.
• Chair Product Safety Committee meetings and escalate critical safety concerns to executive leadership as needed.
• Conduct medical reviews and causality assessments using data from preclinical studies, clinical trials, post-marketing surveillance, and literature.
• Provide medical input on regulatory documents such as INDs, NDAs, BLAs, protocols, informed consent forms, investigator brochures, and clinical study reports.
• Oversee the preparation of aggregate safety reports and signal evaluation documentation.
• Respond to regulatory inquiries related to safety topics with clinical and scientific insight.
• Guide and support CRO teams to ensure high-quality delivery of outsourced medical safety activities.
• Collaborate with internal safety scientists and contribute to SOP development to maintain regulatory compliance.
• Organize and lead internal and external meetings, including data monitoring committees and vendor oversight sessions.
• Foster strong cross-functional relationships and demonstrate adaptability in a dynamic environment.
• Promote continuous improvement and training initiatives within the safety function.

Qualifications

• Medical degree (MD, MBBS or equivalent).
• Minimum of 7 years of experience in pharmaceutical drug safety and pharmacovigilance.
• In-depth knowledge of US and EU safety regulations.
• Experience supporting safety activities in pivotal clinical trials.
• Strong medical judgment with the ability to align clinical insights with business needs.
• Proven analytical and scientific reasoning skills.
• Comprehensive understanding of drug development from discovery through post-market surveillance.
• Prior experience with regulatory submissions (IND, NDA, BLA) and interactions is highly preferred.
• Demonstrated success in leading teams within a matrixed environment.
• Excellent organizational, leadership, and communication skills, with the ability to translate complex data into actionable strategies.