Job Title: Pharmacovigilance Quality Assurance Manager
Location: [Not Specified]
Company: Vizen Life Sciences Pvt. Ltd.
Job Type: Full-Time
About the Company:
Vizen Life Sciences Pvt. Ltd. is a growing organization committed to excellence in pharmacovigilance and life sciences services. With a strong focus on compliance, quality, and patient safety, the company provides innovative solutions to ensure global pharmacovigilance standards are met and exceeded.
Role Overview:
We are seeking an experienced Pharmacovigilance Quality Assurance (PV-QA) professional to lead and manage the PV QA function. The candidate will be responsible for driving compliance, overseeing quality systems, managing audits, and leading a skilled team to ensure global pharmacovigilance standards are consistently upheld.
Key Responsibilities:
Independent Quality Review:
Conduct independent quality reviews of Individual Case Safety Reports (ICSRs) (mandatory).
Oversee quality review of aggregate reports (preferred).
Quality Management System:
Develop and maintain the full life cycle of SOPs.
Manage change control systems.
Lead investigations, root cause analyses (RCA), corrective actions, and monitoring effectiveness.
Implement process improvements and best practices for PV QA.
Training Management:
Maintain and update training matrices.
Identify training needs and implement effective training programs.
Audit Readiness:
Prepare and support internal audits and health authority inspections.
Respond to findings and implement CAPA measures.
Compliance & Risk Mitigation:
Conduct compliance monitoring across multiple projects.
Facilitate regular quality review meetings.
Experience Requirements:
10–15 years in Pharmacovigilance Quality Assurance.
Prior experience in both PV operations and PV-QA preferred.
Proven track record of people management.
Experience in pharmaceutical companies and/or service-based organizations.
Education Requirements:
Bachelor’s or Master’s degree in Pharmacy or related field.
Skills:
Excellent verbal and written communication.
Strong client handling and stakeholder management abilities.
Proficient in presentation skills with the ability to engage diverse audiences.
Why Join Us?
This is a unique opportunity to lead a critical function in ensuring the safety, compliance, and quality of pharmacovigilance processes. You will play a key role in shaping organizational excellence and driving continuous improvement within a dynamic and collaborative environment.
Estimated Salary: ₹25 – 40 LPA (based on senior PV-QA leadership roles in India).
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