Job Description

Position: Executive – R&D Quality, GPvP-QA _ Pharmacovigilance as PV-QA auditor

Grade: G12A

No of Positions: 2 No.

Job Location: Gurgaon

Job Responsibilities

• 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 being a lead auditor/co-auditor for Sun Pharma sites associated with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.
• Assist in conducting and reporting audits being a lead auditor/co-auditor for conducting and reporting audits being a lead auditor/co-auditor for outsourced parties (CROs, Service Providers, Vendors etc.), Affiliates & Partners etc.
• To assist for the preparation and maintenance of CAPA tracker and assure that the CAPAs are adequately addressed and closed.
• Responsible for review of Pharmacovigilance SOPs for completeness, clarity, and compliance to global/regional policies, and applicable regulatory regulations & guidelines.
• Maintenance up to date and in accordance with global expectation a quality system supporting companies supporting PI management
• Review of PSMFs of assigned countries
• Provide support in risk assessment of business partners.
• Participate during qualification of identified vendors for Pharmacovigilance support.
• 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.
• Responsible for updation of audit master schedule for the GPvP QA audits.
• To review and close deviations raised at global and regional levels in order to ensure adequacy of associated CAPA.
• To perform any other responsibilities assigned by the head GPvP-QA on as and when required basis
  
  

Key Word for Search in Job Site: Pharmacovigilance Quality Assurance, Auditing, R&D Quality, RQA, and marketed product

Desired Candidate Profile

• M. Pharm with 2-3 years of experience in PV-QA or Pharmacovigilance operations.
• It is preferred is well aware about GVP modules
• Good oral and written communication skill