AD/Director PV Operations

The individual will oversee the daily operations of the Pharmacovigilance function, ensuring adherence to standard operating procedures, policies, industry best practices, and relevant regulations.

Primary Responsibilities:

• Oversee the daily management and execution of pharmacovigilance (PV) operations.
• Ensure compliance with regulatory requirements, PV agreements, and internal SOPs.
• Act as a representative for the Drug Safety and Pharmacovigilance departments on clinical development teams.
• Supervise the processing of Serious Adverse Events (SAEs) by outsourced vendors and monitor compliance operations.
• Develop and implement strategies to maintain high-quality standards by analyzing and mitigating compliance risks.
• Manage SAEs, including case triage, data entry, coding review, and narrative writing.
• Provide support for safety operations in external submissions, signal detection, and risk management planning.
• Assist in the preparation of periodic safety reports (e.g., DSUR, PSUR).
• Ensure the compliant exchange of safety data between the company and its partners.
• Collaborate with the quality management system in Drug Safety to ensure department standards are met, including training, performance monitoring, continuous improvement actions, and good documentation practices.
• Work with the QA department to maintain high PV inspection readiness across all regions/countries.
• Collaborate with contract service providers for case processing, aggregate reporting, and quality management activities.
• Manage the performance of PV systems.
• Support root cause analysis of deviations relevant to PV systems.
• Participate in regulatory inspections and company audits, including FDA/MHRA/EMA PV inspections.
• Prepare responses to audit findings related to the PV department.
• Manage reconciliation activities with other departments and vendors.
• Provide project management support for NDA/MAA submission activities and prepare safety data submissions.
• Support cross-functional teams in patient narrative efforts.
• Provide strategic oversight of vendors.
• Manage the quality and compliance of assignments, including training and mentoring.