Pharmacovigilance Quality Assurance Manager

Are you a seasoned professional in Pharmacovigilance Quality AssuranceWe are looking for a Pharmacovigilance QA Head to lead and manage our PV QA function, ensuring excellence in compliance and quality standards. Key Responsibilities: Team Management & Oversight of following: 1. Independent quality review of ICSRs: Conduct independent quality reviews for Individual Case Safety Reports (ICSRs) with a strong understanding of the ICSR process (Must have) Oversee the quality review of aggregate reports (Preferred). 2. Quality Management System: Develop and maintain life cycle of Standard Operating Procedures (SOPs). Manage the change control system. Address process non-conformance, including investigations, root cause analyses (RCA), corrective actions, monitoring effectiveness, and trend analysis. Process improvements and implement best practices for PV QA methodologies. 3. Training Management: Maintain and update training matrices. Identify training needs and ensure the delivery of effective training programs. 4. Audit Readiness: Prepare for audits by facilitating data requests and communication for internal and health authority inspections. Respond to audit findings and implement corrective and preventive actions accordingly. 5. Compliance Monitoring & Risk Mitigation of multiple projects with defined frequency 6. Conduct Quality review meetings Experience: - 10-15 years in Pharmacovigilance Quality Assurance (PV-QA). - Preferable experience in Pharmacovigilance operations and PV-QA - Proven track record of Previous People Management. - Experience in both pharmaceutical companies and service-based organizations. Education: - Bachelor s or Master s degree in Pharmacy or a related field. Skills: - Excellent verbal and written communication. - Strong client handling abilities. - Proficient in presentation skills to effectively convey information and engage stakeholders. Why Join Us This is a unique opportunity to lead a critical function in ensuring the safety and compliance of pharmacovigilance processes. If you re passionate about quality assurance and have a proven track record of leading successful teams,.