Job highlights

- Education: . - Bachelor s or Master s degree in Pharmacy or a related field
- Conduct independent quality reviews for Individual Case Safety Reports (ICSRs) with a solid understanding of the ICSR process (Must have).

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).

1. 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.

1. Training Management:

- Maintain and update training matrices.
- Identify training needs and ensure the delivery of effective training programs.

1.



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.

1. Compliance Monitoring & Risk Mitigation of multiple projects with defined frequency

2. 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,.

📌 Pharmacovigilance Quality Assurance Manager (Hyderabad)
🏢 Vizen Life Sciences
📍 Hyderabad