We are hiring a Pharmacovigilance Quality Assurance (PV QA) Specialist for our team in Pune. The ideal candidate will have 3-5 years of direct experience in PV QA with a strong understanding of Good Pharmacovigilance Practices (GVP), audits, and compliance.
Key Responsibilities:
- Conduct internal and external audits to ensure compliance with global pharmacovigilance regulations (EMA, FDA, ICH-GCP).
- Review and assess Pharmacovigilance System Master Files (PSMF), SOPs, and risk management plans.
- Ensure adherence to GVP, GMP, and regulatory requirements in drug safety processes.
- Identify compliance gaps and implement corrective and preventive actions (CAPA).
- Collaborate with cross-functional teams to maintain quality and compliance standards in pharmacovigilance.
- Support regulatory inspections and audit readiness activities.
Desired Skills & Qualifications:
- 3-5 years of experience in Pharmacovigilance Quality Assurance (PV QA).
- Strong knowledge of GVP, ICH-GCP, and global pharmacovigilance regulations.
- Experience in GMP or manufacturing QA is a plus.
- Excellent audit, compliance, and documentation skills.
- Ability to work in a fast-paced, regulated pharmaceutical environment.
About the Company
PharmaBharat.com is a leading platform for pharmaceutical and life sciences professionals, providing job opportunities, industry news, and career growth resources. We partner with top pharmaceutical companies to connect talent with the right opportunities.
How to Apply?
If you meet the qualifications and are interested in this PV QA role in Pune, please send your updated resume to:
📩 Email: varsha.kamalapurkar@wipro.com
🔹 Subject Line: “Application for PV QA Specialist – Pune – [Your Name]”Pharmacovigilance Quality Assurance (PV QA) Specialist
