About the role
Are you a seasoned professional in Pharmacovigilance Quality Assurance? We 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,.