- Pharmacovigilance (PV) Quality Assurance System Governance.
- Maintaining oversight of the quality systems within Pharmacovigilance department.
- Review &/or Approval of Quality system documents related to Pharmacovigilance.
- Ensure compliance with written procedures/policy/manuals.
- Ensure all time readiness of Pharmacovigilance function for client audits/visits and regulatory inspections.
- Handling of External Audits, Regulatory Inspections, & client visits related to Pharmacovigilance function.
- Monitor the deficiencies and deviations within PVD and shall ensure compliance and implementation of Corrective and Preventive Actions (CAPA) in accordance with relevant QMS SOP.
- On-boarding & training of current joinee within PVD – Compliance with defined requirements and completeness of Individual training plans, on-job trainings, Job Responsibilities etc
- Perform quality review of PV activities to monitor the PV process on regular basis.
- Conducting or Assisting in QMS Audits, Vendor Qualification Audits, For Cause Audits and Pre-Inspection Audits for PV function of Pharmazone.
- Addressing external queries pertaining to quality and compliance of PV.
- Distribution of documents to the PV personnel after coordinating with Quality Management System department.
- Any other responsibilities assigned by management time to time.
Department: Pharmacovigilance
Job Category: PV - QA
Vacancy: 1
Qualification: BDS B. Pharm. M. Pharm.
Experience: 3-4 YEARS
Job Code: PZPV015
Job Location: Ahmedabad
📌 Senior Executive – Pharmacovigilance (India)
🏢 Pharmazone
📍 India
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