Executive- QA Pharmacovigilance

3 days ago

haryana, India Sun Pharmaceutical Industries, Inc. Full time

Title: Executive- QA PharmacovigilanceDate: Oct 7, 2025Location: Gurgaon - OfficeCompany: Sun Pharmaceutical Industries LtdDepartment: R&D Quality (GPvP QA)Designation: Executive (QA Pharmacovigilance)Location: GurgaonJOB DESCRIPTION (JD)Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor/co-auditor for outsourced parties (CROs, Service Providers, Vendors), Affiliates & Partners etc., associated with Sun Pharma Pharmacovigilance operations.Assist in conducting and reporting audits for Sun Pharma sites associate with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.Management of Internal Audit Observation Database (IAOD) with the perspective of sharing audit reports, CAPA reports and observation of global impact with all internal regional PV sites across the globe and Global Pharmacovigilance.To assure that the CAPAs are adequately addressed and closed.To review and close deviations raised at global and regional levels in order to ensure adequacy of associated CAPA.Responsible for review of Pharmacovigilance SOPs for completeness, clarity, and compliance to global/regional policies, and applicable regulatory regulations & guidelines.To prepare and review departmental SOPsTo assist in monthly report preparationManagement training and records of GPvP-QA team through LMSSupport operations team during corporate audit/ external auditsCollaborate with cross-functional teams to ensure quality standards are met across all pharmacovigilance activities.Lead the assessment, tracking of global actions and monitoring of identified actions as part of various corporate initiatives.To perform any other responsibilities assigned with regards to the R&D Quality system.Maintain documentation and records in accordance with quality and regulatory standards.Education and Experience:Post Graduate in Pharmacy (M. Pharma) OR BDSAround 2 years of experience in Pharmacovigilance Quality Assurance OR 2 years' experience in PSUR/Signal managementTechnical Competencies:Auditing skillsAttention to detailBehavioural Competencies / Soft Skills:Good spoken and written EnglishLiaising with different teams

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