Pharmacovigilance Quality Assurance Manager

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,.