Executive- Qa Pharmacovigilance

3 weeks ago


Gurgaon Haryana, India Sun Pharmaceutical Industries Full time

Department R D Quality GPvP QA Designation Executive QA Pharmacovigilance Location Gurgaon JOB 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 SOPs To assist in monthly report preparation Management training and records of GPvP-QA team through LMS Support operations team during corporate audit external audits Collaborate 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 BDS Around 2 years of experience in Pharmacovigilance Quality Assurance OR 2 years experience in PSUR Signal management Technical Competencies Auditing skills Attention to detail Behavioural Competencies Soft Skills Good spoken and written English Liaising with different teams



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