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Pharmacovigilance Quality Assurance Manager

10-15 years
₹25 – 40 LPA
10 Aug. 21, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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).