Director , Medical Safety

Job Summary:The Director of Medical Safety is responsible for overseeing and ensuring the safety and pharmacovigilance of all clinical and post-marketing activities related to the company's pharmaceutical products. The Director will provide strategic leadership and medical oversight in the evaluation, monitoring, and risk management of product safety. This role requires strong expertise in pharmacovigilance, regulatory compliance, and risk assessment, as well as the ability to lead and collaborate cross-functionally to ensure the companys products meet the highest standards of patient safety

Key Responsibilities:1. Medical Safety Leadership: Lead the development, implementation, and oversight of the companys pharmacovigilance strategy to ensure the safety of drugs throughout their lifecycle (pre-approval and post-marketing). Provide medical oversight and expertise on all safety-related aspects of clinical trials, adverse event reporting, and risk management activities. Act as the primary medical point of contact for internal stakeholders (e.g., clinical development, regulatory affairs, commercial, and legal teams) regarding drug safety and medical risk.2. Pharmacovigilance & Safety Data Management: Oversee the collection, evaluation, and reporting of adverse events, product complaints, and safety data from clinical trials, post-marketing surveillance, and other sources (e.g., literature). Ensure timely and accurate submission of pharmacovigilance data to regulatory agencies (FDA, EMA, etc.) in compliance with local and international regulations. Conduct regular safety data analysis and signal detection to identify potential safety concerns and advise on risk mitigation strategies. Lead the preparation and submission of safety reports, including Periodic Safety Update Reports (PSURs), Risk Evaluation and Mitigation Strategies (REMS), and other regulatory safety documents.3. Risk Management and Mitigation: Develop and oversee risk management strategies for existing and pipeline products, including risk assessments, risk minimization strategies, and safety communication. Ensure that appropriate safety data is incorporated into product labeling, Risk Management Plans (RMP), and Risk Communication Plans. Lead the preparation and presentation of safety data during product development meetings, clinical trial steering committees, and regulatory agency interactions.4. Cross-Functional Collaboration: Collaborate closely with clinical development teams to ensure safety considerations are integrated into study designs, trial protocols, and monitoring plans. Work with regulatory affairs teams to provide safety-related information for regulatory filings and product approvals. Coordinate with commercial teams to ensure that safety information is communicated appropriately to healthcare professionals and patients. Support the preparation of responses to regulatory queries regarding drug safety.5. Safety Oversight & Monitoring: Lead and oversee the safety surveillance of marketed products, ensuring appropriate monitoring of post-marketing safety data, including patient registries and pharmacovigilance databases. Conduct periodic safety reviews and risk assessments, including aggregate safety analyses and benefit-risk assessments. Ensure compliance with global safety regulations, including those related to adverse event reporting, labeling, and product recalls.6. Team Leadership & Development: Build and lead a high-performing pharmacovigilance and safety team, providing mentoring, coaching, and performance management. Ensure team members are properly trained on regulatory requirements, safety protocols, and industry best practices. Promote a culture of continuous improvement, innovation, and compliance within the medical safety team.7. Stakeholder Communication & Reporting: Prepare and present safety data and risk management information to senior leadership, regulatory authorities, and external stakeholders (e.g., Advisory Boards, Health Authorities). Lead discussions in safety review boards, and present safety data at internal and external meetings, including advisory boards, investor relations meetings, and regulatory agency submissions.

Skills & Qualifications:Experience: Minimum of 10+ years of experience in pharmacovigilance, drug safety, or medical affairs, with at least 5+ years in a leadership role. Extensive experience in clinical trial safety, post-marketing pharmacovigilance, and regulatory affairs related to drug safety. Deep understanding of global pharmacovigilance regulations (FDA, EMA, ICH, WHO, etc.), safety reporting requirements, and risk management practices. Experience in conducting benefit-risk assessments, signal detection, and safety data analysis.Education: Medical degree (MD, DO, or equivalent) preferred. Alternatively, a PhD or PharmD in a related field may be considered. Additional certifications in pharmacovigilance or safety (e.g., Board Certification in Pharmacovigilance or Clinical Safety) would be a plus.

Skills: Strong leadership and management skills, with the ability to lead cross-functional teams and interact effectively with senior management. Excellent communication and interpersonal skills, with experience in preparing and presenting safety data to regulatory authorities and senior leadership. Proficient in safety reporting systems, including case management software, signal detection tools, and regulatory submission platforms. Strategic thinking and problem-solving skills, with the ability to balance the need for patient safety with business objectives. Knowledge of regulatory submission processes and the ability to communicate and collaborate with regulatory agencies.Additional Skills: Strong understanding of clinical development processes, from preclinical to post-marketing. Ability to work in a fast-paced, dynamic environment while managing competing priorities. Proficiency in data analysis and risk management tools (e.g., Argus, Oracle Safety, etc.).