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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, MPMD, PSPV based in India.
This role provides global medical and scientific leadership within patient safety and pharmacovigilance, with responsibility for defining and executing end-to-end safety strategy across assigned products in a complex, regulated environment. You will act as a Global Safety Lead, overseeing benefit-risk evaluation, signal management, and the development of robust safety deliverables across the product lifecycle. The position requires close collaboration with cross-functional global teams and regulatory authorities to ensure that safety insights are accurately interpreted and effectively integrated into clinical and post-marketing decision-making. You will play a key role in shaping safety governance, guiding risk mitigation strategies, and ensuring regulatory readiness of all safety outputs. This is a high-impact leadership role operating at the intersection of clinical development, regulatory science, and pharmacovigilance. It offers exposure to global programs, high-stakes decision-making, and the opportunity to directly influence patient safety outcomes worldwide.
Accountabilities:
- Serve as Global Safety Lead for assigned products, defining and executing the overall safety strategy across the product lifecycle.
- Lead global safety governance teams, ensuring alignment on safety priorities, timely decisions, and cross-functional coordination.
- Conduct safety data analysis from clinical, non-clinical, post-marketing, and real-world evidence sources to support benefit-risk evaluation.
- Oversee signal detection, assessment, and management activities in compliance with global pharmacovigilance regulations.
- Author, review, and contribute to key regulatory and clinical safety documents including protocols, IBs, CSRs, IMPDs, INDs, BLAs, and risk management plans.
- Develop and communicate safety insights to internal governance bodies, regulatory agencies, and external stakeholders.
- Support regulatory interactions and responses related to safety queries, ensuring scientific rigor and compliance.
- Integrate safety considerations into clinical development strategies, study design, and lifecycle management plans.
- Mentor and guide pharmacovigilance physicians and safety scientists, strengthening organizational capability and consistency.
Requirements:
- Medical degree (MD, DO, or equivalent) with clinical training and strong grounding in medicine, epidemiology, and biostatistics.
- Minimum 5 years of experience in drug safety or pharmacovigilance, including at least 3 years in post-marketing safety.
- Strong expertise in signal detection, benefit-risk assessment, aggregate reporting, and safety surveillance.
- Solid understanding of global regulatory frameworks including FDA, EMA, PMDA, and ICH guidelines.
- Experience interacting with regulatory authorities and responding to complex safety-related inquiries.
- Strong scientific judgment with the ability to make decisions in ambiguous or data-limited environments.
- Excellent communication and stakeholder management skills in global, matrixed organizations.
- Demonstrated ability to influence cross-functional teams and drive alignment without direct authority.
- Exposure to advanced methodologies or digital tools in pharmacovigilance (e.g., AI or quantitative approaches) is a plus.
Benefits:
- Competitive executive-level compensation package aligned with global industry standards.
- Remote or hybrid work flexibility with global collaboration opportunities.
- Comprehensive health, wellness, and insurance coverage.
- Paid time off and supportive work-life balance policies.
- Opportunities for international exposure and cross-functional leadership engagement.
- Access to continuous medical education and professional development programs.
- High-impact role contributing directly to patient safety at a global scale.
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