Pharmacovigilance Quality Assurance (PV-QA) Manager
Company: Vizen Life Sciences Pvt. Ltd
Location: India (Hyderabad / Remote Flexible)
Employment Type: Full-Time
Experience Required: 10–15 Years
Educational Qualification: Bachelor’s or Master’s degree in Pharmacy or Life Sciences
Job Overview
Vizen Life Sciences is seeking a highly experienced Pharmacovigilance Quality Assurance (PV-QA) Manager to lead and oversee our PV QA function. This role ensures compliance, quality excellence, and continuous improvement across all pharmacovigilance operations, including ICSRs, aggregate reporting, SOP management, training, audit readiness, and risk mitigation.
The ideal candidate will combine deep knowledge of PV-QA processes, regulatory compliance, and team leadership to drive operational excellence across multiple projects and stakeholders.
Key Responsibilities
1. Team Management & ICSR Quality Oversight
Conduct independent quality reviews of Individual Case Safety Reports (ICSRs) with a thorough understanding of the PV process.
Oversee quality review of aggregate safety reports where applicable.
Lead PV QA meetings and provide guidance to QA and operational teams.
2. Quality Management System (QMS)
Develop, maintain, and review Standard Operating Procedures (SOPs) across the PV lifecycle.
Manage change control systems and process updates.
Address process non-conformance, including investigations, root cause analysis (RCA), corrective and preventive actions (CAPA), monitoring effectiveness, and trend analysis.
Implement process improvements and best practices for PV QA methodologies.
3. Training Management
Maintain and update training matrices for PV and QA teams.
Identify training needs and ensure delivery of effective programs to enhance competency and compliance.
4. Audit Readiness & Regulatory Support
Prepare for internal and health authority audits/inspections, facilitating data requests and communications.
Respond to audit findings and oversee implementation of corrective and preventive actions (CAPAs).
Ensure PV operations are audit-ready at all times and compliant with regulatory expectations.
5. Compliance Monitoring & Risk Mitigation
Monitor compliance across multiple projects, maintaining risk-based oversight.
Implement strategies to mitigate potential compliance and operational risks.
Required Qualifications and Experience
Experience: 10–15 years in Pharmacovigilance Quality Assurance (PV-QA).
Hands-on experience in PV operations and PV-QA processes.
Proven experience in people management and leading QA teams.
Exposure to pharmaceutical companies and service-based organizations.
Strong knowledge of regulatory requirements for PV compliance (ICH-GCP, GVP, FDA, EMA).
Key Skills & Competencies
Independent quality review of ICSRs and aggregate reports.
Quality Management System (QMS) development and implementation.
Audit preparation, inspection readiness, and regulatory compliance.
Root Cause Analysis (RCA) and CAPA management.
Training development and delivery for PV teams.
Strong verbal, written, and presentation skills.
Client handling and stakeholder engagement.
Why Join
Lead a critical function in PV compliance and quality assurance.
Influence and improve pharmacovigilance processes and standards across global operations.
Work in a dynamic, collaborative, and regulatory-focused environment.
Opportunity to mentor teams and drive operational excellence in PV-QA.
Apply now to join Vizen Life Sciences as a Pharmacovigilance QA Manager and contribute to maintaining the highest standards in patient safety and regulatory compliance.
Explore more global pharmacovigilance, QA, and clinical operations roles at
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