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.
