Executive Director – Head of Pharmacovigilance – Safety Science

Executive Director – Head of Pharmacovigilance – Safety Science

Requirements

• MD or equivalent (MBBS etc)
• 10+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry
• Oncology experience
• Experience with global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH
• Demonstrable understanding of clinical development, post-marketing safety, and regulatory submissions
• Demonstrated expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting
• Experience interacting with global regulatory authorities and scientific advisory bodies

Responsibilities

• Develop and lead the global pharmacovigilance strategy to ensure proactive risk management and compliance with local and international PV regulations (e.g., FDA, EMA, ICH)
• Oversee safety operations team members and vendors in managing end-to-end PV activities, including case processing, safety surveillance, risk management, aggregate reporting and signal detection and assessment
• Establish and maintain robust safety governance structures and standard operating procedures, ensuring alignment with company objectives and industry best practices
• Ensure collaboration with BMS safety and clinical development leadership
• Direct safety evaluation and risk management for clinical development and post-marketing products, including benefit-risk assessments and product safety strategy
• Lead the detection, evaluation, and management of safety signals, collaborating with cross-functional teams to implement risk minimization strategies and communicate potential safety concerns
• Represent safety science for health authority interactions and drive safety related content of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries
• Contribute to understanding and managing the AE profile of products in development and ensure protocols ensure appropriate safety management in all phases of clinical trials
• Lead the strategy and review of safety modules and risk management plans in regulatory filings
• Contribute to the development of risk/benefit analyses in regulatory filings and HTA submissions
• Partner with clinical, regulatory, and medical affairs teams to integrate safety insights into product development, clinical trial design, and labeling strategies
• Act as the key PV representative for interactions with global regulatory authorities and stakeholders, advocating for patient safety
• Engage with external experts, scientific bodies, and industry groups to stay updated on evolving PV practices and enhance the organization’s safety profile
• Lead and mentor a high-performing pharmacovigilance team, fostering a culture of collaboration, accountability, and scientific excellence
• Define and implement processes for continuous improvement within safety science, and risk management

Preferred Qualifications

• Radiopharmaceutical experience