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Executive- Qa Pharmacovigilance

2+ years
Not Disclosed
10 Oct. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Executive – QA Pharmacovigilance

🏢 Company: Sun Pharmaceutical Industries Ltd
📍 Location: Gurgaon, India
📅 Date Posted: 07 Oct 2025
💼 Department: R&D Quality (GPvP QA)
📝 Designation: Executive (QA Pharmacovigilance)


Job Purpose

Assist in ensuring the quality and compliance of pharmacovigilance operations by supporting audits, SOP reviews, CAPA management, and global PV quality initiatives in line with regulatory and company standards.


Key Responsibilities

Audit & Quality Assurance

  • Assist in developing the global pharmacovigilance system auditing program.

  • Conduct and report audits as lead auditor/co-auditor for:

    • Outsourced parties (CROs, Service Providers, Vendors)

    • Affiliates and Partners

    • Sun Pharma internal sites associated with PV operations.

  • Manage the Internal Audit Observation Database (IAOD) to share audit reports, CAPA reports, and global impact observations.

  • Ensure CAPAs are adequately addressed and closed.

  • Review and close deviations raised at global and regional levels.

  • Support operations during corporate and external audits.

SOP & Documentation Management

  • Review Pharmacovigilance SOPs for completeness, clarity, and compliance with global/regional policies and applicable regulatory guidelines.

  • Prepare and review departmental SOPs.

  • Maintain documentation and records in accordance with quality and regulatory standards.

  • Assist in monthly report preparation.

  • Manage training records of GPvP-QA team through LMS.

Cross-functional Collaboration & Monitoring

  • Collaborate with cross-functional teams to ensure quality standards are met across all pharmacovigilance activities.

  • Lead the assessment, tracking, and monitoring of global actions as part of corporate initiatives.

  • Perform additional responsibilities assigned with regards to the R&D Quality System.


Education & Experience

  • Postgraduate in Pharmacy (M. Pharma) OR BDS.

  • Around 2 years of experience in:

    • Pharmacovigilance Quality Assurance, OR

    • PSUR / Signal Management.


Technical Competencies

  • Strong auditing skills.

  • Attention to detail.


Behavioral / Soft Skills

  • Good spoken and written English.

  • Ability to liaise effectively with multiple teams.


Summary:
This role is ideal for a quality-focused pharmacovigilance professional with auditing experience, strong attention to detail, and the ability to collaborate across global teams to maintain PV compliance and operational excellence.