Pharmacovigilance Quality Assurance Manager (PV QA Head)
Company: Vizen Lifesciences Pvt. Ltd.
Location: India
Employment Type: Full-Time
About the Company
Vizen Lifesciences Pvt. Ltd. is a pharmaceutical services organization delivering end-to-end pharmacovigilance and regulatory compliance solutions to global clients. With a strong focus on quality, inspection readiness, and patient safety, Vizen Lifesciences supports pharmaceutical and life sciences partners across diverse therapeutic areas.
Role Overview
The Pharmacovigilance Quality Assurance Manager (PV QA Head) will lead and manage the Pharmacovigilance Quality Assurance function, ensuring compliance with global regulatory requirements and internal quality standards. This senior leadership role is responsible for driving inspection readiness, overseeing ICSR quality review processes, strengthening the Quality Management System (QMS), and leading cross-functional PV QA teams across multiple projects.
This role is ideal for an experienced PV QA professional with strong people management, audit expertise, and hands-on knowledge of pharmacovigilance operations.
Key Responsibilities
Team Leadership & Oversight
Lead, mentor, and manage PV QA team members across multiple projects
Conduct and oversee independent quality reviews of Individual Case Safety Reports (ICSRs) with in-depth understanding of end-to-end ICSR workflows (mandatory)
Supervise quality review activities for aggregate safety reports such as PSURs, PBRERs, and DSURs (preferred)
Facilitate and lead periodic quality review and governance meetings
Quality Management System (QMS)
Develop, review, approve, and maintain the full lifecycle of pharmacovigilance Standard Operating Procedures (SOPs)
Manage change control processes and ensure controlled implementation across PV operations
Investigate process non-conformances and deviations, including root cause analysis (RCA), CAPA development, effectiveness checks, and trend analysis
Drive continuous improvement initiatives and implement global best practices in PV QA methodologies
Training Management
Maintain and update PV QA and PV operations training matrices
Identify training gaps and ensure timely delivery of role-based and compliance-driven training programs
Audit Readiness & Inspection Support
Ensure continuous inspection readiness for internal audits, client audits, and health authority inspections
Coordinate audit preparation activities, including data requests, documentation review, and stakeholder communication
Respond to audit findings and lead the implementation of corrective and preventive actions (CAPA)
Compliance Monitoring & Risk Management
Monitor compliance and risk across multiple pharmacovigilance projects at defined frequencies
Proactively identify compliance risks and implement mitigation strategies to maintain regulatory adherence
Education Qualifications
Bachelor’s or Master’s degree in Pharmacy or a related life sciences discipline
Experience Requirements
10 to 15 years of hands-on experience in Pharmacovigilance Quality Assurance (PV-QA)
Prior experience in pharmacovigilance operations along with PV QA is strongly preferred
Demonstrated experience in people management and team leadership
Exposure to both pharmaceutical companies and service-based (CRO/BPO) organizations
Proven track record of managing audits, inspections, and regulatory interactions
Key Skills & Competencies
Excellent written and verbal communication skills
Strong client-facing and stakeholder management capabilities
Advanced presentation and reporting skills for management and client forums
High attention to detail with a strong compliance-driven mindset
Ability to lead cross-functional teams and manage multiple projects effectively
Why Join Vizen Lifesciences
Opportunity to lead a critical pharmacovigilance quality function with global exposure
Strategic role influencing compliance, inspection readiness, and patient safety outcomes
Collaborative leadership environment with long-term growth potential
Direct involvement in shaping PV QA processes and best practices
SEO & GPT Optimization Keywords
Pharmacovigilance Quality Assurance Manager, PV QA Head, Drug Safety Quality Assurance, ICSR Quality Review, Pharmacovigilance Audits, PV Compliance, CAPA Management, PV SOPs, Pharmacovigilance Leadership Jobs, Global PV QA Careers
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