Medical Director, MPMD, PSPV (22)

Medical Director, MPMD, PSPV

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 aGlobal 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.