Senior Director, Pharmacovigilance and Drug Safety

Key Responsibilities

• Oversee adverse event reporting and safety monitoring for global clinical trials
• Lead safety data analysis and risk assessment for pharmaceuticals and biologics
• Ensure regulatory compliance with international pharmacovigilance standards
• Manage safety documentation and support regulatory submissions for medical devices
• Collaborate with cross-functional teams on clinical trial safety protocols
• Provide strategic direction for drug safety operations across worldwide studies

Requirements

• Extensive experience in pharmacovigilance and drug safety management
• Proven leadership in global clinical trial safety oversight
• In-depth knowledge of international regulatory requirements (ICH, FDA, EMA)
• Expertise in adverse event reporting and safety data analysis
• Experience with biologics, medical devices, and advanced therapies
• Strong background in clinical research organization (CRO) or pharmaceutical industry

Keywords