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Pharmacovigilance Qa Auditor

2+ years
Not Disclosed
10 Nov. 10, 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

Job Title: Pharmacovigilance QA Auditor
Company: Sun Pharmaceutical Industries Ltd
Business Unit: R&D Quality
Job Grade: Executive / G12A
Location: Gurugram, Haryana, India
Date Posted: Nov 5, 2025

Company Overview:
At Sun Pharma, employees are encouraged to “Create your own sunshine” by fostering growth, self-drive, collaboration, and continuous improvement. The company emphasizes professional development, teamwork, and supportive work culture.

Role Summary:
As a Pharmacovigilance QA Auditor, you will assist in developing and executing the global pharmacovigilance auditing program, ensuring compliance with internal quality systems, regulatory guidelines, and global pharmacovigilance standards.

Key Responsibilities:

  • Develop and execute global pharmacovigilance system auditing programs.

  • Conduct and report audits as lead auditor/co-auditor for outsourced parties (CROs, service providers, vendors), affiliates, partners, and Sun Pharma sites.

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

  • Ensure CAPAs are addressed and closed appropriately.

  • Review and close deviations at global and regional levels.

  • Review and prepare Pharmacovigilance SOPs for clarity, compliance, and regulatory alignment.

  • Assist in monthly report preparation and maintain records via LMS for GPvP-QA team.

  • Support operations during corporate or external audits.

  • Collaborate with cross-functional teams to ensure quality standards across PV activities.

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

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

  • Perform other responsibilities assigned within the R&D Quality system.

Qualifications:

  • Required: Post Graduate in Pharmacy (M.Pharm) or BDS.

Experience:

  • Approximately 2 years in Pharmacovigilance Quality Assurance OR 2 years’ experience in PSUR/Signal management.

Technical Competencies:

  • Auditing skills

  • Attention to detail

Behavioral Competencies / Soft Skills:

  • Good spoken and written English

  • Ability to liaise with different teams and stakeholders

Travel Estimate:

  • Low

Additional Information:

  • Sun Pharma provides robust benefits, professional growth opportunities, and a supportive work environment.

  • Job description may evolve; employees may be assigned comparable duties commensurate with experience.