Are you an experienced Pharmacovigilance Quality Assurance (PV-QA) professional looking for a leadership role? Vizen Life Sciences is hiring a Pharmacovigilance QA Manager to oversee and enhance our PV compliance and quality standards.
Key Responsibilities:
1. Team Management & Oversight
- Lead and manage the PV Quality Assurance team, ensuring adherence to global pharmacovigilance regulations.
2. Independent Quality Review of ICSRs
- Conduct quality checks for Individual Case Safety Reports (ICSRs) (Must Have).
- Oversee aggregate reports (PBRERs, DSURs) quality review (Preferred).
3. Quality Management System (QMS)
- Develop, review, and maintain SOPs, Work Instructions, and Process Documents.
- Manage change control, deviations, CAPA, and root cause analysis (RCA).
- Drive process improvements and implement best practices in PV QA.
4. Training Management
- Maintain training matrices and identify skill gaps.
- Ensure effective PV training programs for compliance.
5. Audit & Inspection Readiness
- Prepare for internal audits, regulatory inspections (EMA, FDA, MHRA).
- Address audit findings and implement corrective actions.
6. Compliance Monitoring & Risk Mitigation
- Monitor PV compliance across multiple projects.
- Conduct periodic quality review meetings.
Experience & Qualifications:
- 10-15 years in Pharmacovigilance QA (PV-QA).
- Prior experience in PV Operations & QA (preferred).
- Strong background in people management.
- Worked in pharmaceutical companies or CROs.
- Bachelor’s/Master’s in Pharmacy or Life Sciences.
Required Skills:
✔ Excellent communication & client handling.
✔ Strong presentation & stakeholder management.
✔ Proficient in GxP, ICH-GCP, and global PV regulations.
Why Join Vizen Life Sciences?
- Lead a critical PV QA function in a growing organization.
- Work on global compliance & risk management.
- Opportunity to implement best practices in pharmacovigilance.
About Vizen Life Sciences
Vizen Life Sciences is a leading pharmaceutical & life sciences company specializing in drug safety, regulatory compliance, and pharmacovigilance solutions. We are committed to ensuring patient safety through robust quality systems.
