Medical Director

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Medical Director, Patient Safety and Pharmacovigilance (PSPV), Marketed Products Medical Development (MPMD) based in India.

This role provides strategic and medical leadership for global patient safety across assigned marketed products. You will serve as the Global Safety Lead, shaping end-to-end safety strategies across the product lifecycle. The position plays a critical role in benefit-risk evaluation, signal management, and regulatory readiness. You will collaborate with global, cross-functional teams across clinical development, regulatory, quality, medical affairs, and legal. The role combines scientific judgment, patient safety expertise, and senior stakeholder influence in a high-visibility environment. You will also help anticipate emerging safety risks and develop evidence-based mitigation strategies. This is an opportunity to influence global medicine safety while contributing to continuous innovation in pharmacovigilance.

• Serve as the Global Safety Lead and senior patient-safety subject matter expert for assigned pharmaceutical, biological, and drug-device combination products, defining and executing safety strategies throughout the product lifecycle.
• Lead Global Safety Teams and Safety Management Teams, establishing safety priorities, driving timely decisions, and maintaining clear accountability across functions.
• Evaluate and interpret safety information from clinical and non-clinical studies, post-marketing data, real-world evidence, scientific literature, and other relevant sources.
• Lead signal detection, monitoring, evaluation, interpretation, and management in accordance with global pharmacovigilance requirements and internal procedures.
• Direct cross-functional benefit-risk assessments and ensure accurate, consistent, and timely communication of safety information to senior leadership, governance bodies, regulatory authorities, and other stakeholders.
• Develop and lead scientifically robust responses to safety-related inquiries from regulatory agencies and ethics committees, ensuring materials are consistent and inspection-ready.
• Provide medical safety expertise and review or author safety-related sections of key regulatory and clinical documents, including protocols, investigator brochures, clinical study reports, safety evaluation reports, regulatory submissions, and health hazard assessments.
• Integrate patient-safety considerations into clinical development programs, including study design, statistical analysis planning, safety endpoints, and overall safety characterization.
• Develop, maintain, and communicate product benefit-risk profiles and associated risk-management documentation, including Risk Management Plans.
• Partner with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, Legal, and other functions to align safety messaging and decision-making.
• Support interactions with regulatory authorities and help develop and defend safety positions during submissions, inspections, and regulatory discussions.
• Ensure safety information remains current across core data sheets, reference safety information, investigator brochures, labeling, and other relevant documents.
• Monitor evolving regional and international pharmacovigilance regulations and incorporate changing safety expectations into product strategies.
• Support a high-performing, compliant, and inspection-ready global safety organization through strong governance and consistent application of pharmacovigilance standards.
• Mentor and provide scientific guidance to Pharmacovigilance Physicians and Safety Scientists, strengthening organizational capabilities and consistency of safety assessments.
• Maintain professional expertise through continuing medical education and contribute to a culture of scientific excellence and continuous learning.
• Explore quantitative methodologies and emerging technologies, including AI, to strengthen signal detection and safety surveillance while maintaining scientific rigor and regulatory acceptability.

• Medical degree such as an M.D., D.O., or internationally recognized equivalent, with relevant clinical experience following postgraduate training and strong knowledge of general medicine, epidemiology, and biostatistics; board certification and professional licensure are preferred.
• At least 5 years of experience in Drug Safety or Pharmacovigilance, including 3 or more years in post-marketing safety, with demonstrated expertise in aggregate reporting, safety surveillance, signal management, safety labeling, benefit-risk assessment, and risk management.
• Strong knowledge of national and international pharmacovigilance and regulatory frameworks, including relevant FDA, EMA, PMDA, and ICH guidelines.
• Experience responding to safety-related questions and requests from regulatory authorities and other external stakeholders.
• Strong scientific judgment and the ability to make sound, defensible decisions when working with uncertainty, incomplete evidence, or emerging safety signals.
• Excellent written and verbal communication skills, with the ability to translate complex medical and safety concepts clearly across technical and non-technical audiences.
• Demonstrated ability to influence without direct authority and build alignment across global, matrixed, cross-functional teams.
• Strong prioritization, organization, and independent working skills, with the ability to manage multiple priorities and deliver commitments with limited supervision.
• Collaborative mindset with strong relationship-building and stakeholder-management capabilities, particularly in high-visibility and high-stakes governance environments.