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Executive- Taro Qa Pv Oversight

2-3 years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: M.Pharm 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

 

Title: Executive – Taro QA PV Oversight
Date Posted: April 20, 2025
Location: Gurgaon – Office
Company: Sun Pharmaceutical Industries Ltd


Job Overview:

Sun Pharmaceutical is hiring 2 Executives for its R&D Quality (GPvP-QA) Pharmacovigilance Quality Assurance team in Gurgaon. This position supports the global pharmacovigilance auditing program and ensures compliance with international regulatory standards and internal quality systems. The ideal candidate will serve as a PV-QA auditor, contributing to audit planning, execution, CAPA management, and vendor qualification.


Job Responsibilities:

  • Assist in developing and executing global pharmacovigilance system audit programs.

  • Conduct and report audits (lead/co-auditor) for CROs, vendors, affiliates, and internal Sun Pharma PV sites.

  • Support CAPA tracking, ensuring timely and effective closure.

  • Review pharmacovigilance SOPs for compliance with global regulations (e.g., GVP modules).

  • Support maintenance of a global-quality system for PI (Product Information) management.

  • Review Pharmacovigilance System Master Files (PSMFs) for assigned countries.

  • Participate in business partner risk assessments and vendor qualifications.

  • Manage Internal Audit Observation Database (IAOD) and coordinate global sharing of audit and CAPA reports.

  • Update and maintain the audit master schedule for GPvP QA.

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

  • Perform additional tasks as assigned by the Head of GPvP-QA.


Key Search Terms:

Pharmacovigilance Quality Assurance, Auditing, R&D Quality, RQA, Marketed Product


Candidate Profile:

  • Education: M. Pharm

  • Experience: 2–3 years in Pharmacovigilance QA or PV operations

  • Knowledge: Familiarity with GVP modules preferred

  • Skills: Strong written and verbal communication, good understanding of global PV regulatory expectations


Position Type: Full-Time
Openings: 2
Department: R&D Quality – GPvP-QA