Title:  Executive- QA Pharmacovigilance

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