Director – Pharmacovigilance Safety Operations

Director – Pharmacovigilance Safety Operations

Requirements

• Master’s degree in a scientific or healthcare-related field is required, (MD, PharmD or PhD is preferred)
• Minimum of 10 years of experience in pharmacovigilance and safety operations
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, GVP, FDA, EMA)
• Proven track record of successful collaboration with regulatory authorities and other stakeholders
• Experience in safety operations support to NDA filing and product launches
• Excellent leadership, communication, and interpersonal skills
• Strong analytical and problem-solving abilities
• Ability to work effectively in a fast-paced, dynamic environment

Responsibilities

• Oversee the collection, assessment, and reporting of adverse events and other safety data from clinical trials and post-marketing sources
• Oversee CROs and vendor management of case processing and ensure timely review and reporting of AEs, SAEs, SUSARs etc
• Support safety database processes and transfers to ensure the integrity of the safety database
• Ensure compliance with global pharmacovigilance regulations and guidelines, including timely submission of safety reports to regulatory authorities
• Support NDAs and health authority, third party inspections
• Develop and implement risk management plans, including signal detection, risk assessment, and risk minimization activities
• Collaborate with internal and external stakeholders, including regulatory authorities, healthcare professionals and parent company to ensure effective communication and management of safety issues
• Oversee business partner safety operations requirements e.g. safety data exchange, pharmacovigilance agreements
• Continuously evaluate and improve pharmacovigilance processes and systems to enhance efficiency and effectiveness
• Manage safety CROs and vendors to ensure quality services, meeting compliance and cost efficient processes
• Ensure accurate and comprehensive documentation of safety data and prepare periodic safety update reports (PSURs), development safety update reports (DSURs), and other required regulatory submissions
• Provide training to internal teams and external partners on pharmacovigilance practices and regulatory requirements

Preferred Qualifications

No preferred qualifications provided.