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 ensu...