Position OverviewThe 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 ResponsibilitiesDevelop 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.QualificationsMedical 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.