Medreich Limited – Urgently Opening for Executive – Pharmacovigilance (PVQA) || Apply Now
Responsible for maintaining all aspects of the quality management system in pharmacovigilance.
Ensuring timeline and quality comply with legislation and quality assurance codes.
Identifying training needs and recommendations for annual training plan.
Training new joiners and organizing refresher and new regulations trainings to the team.
Maintenance, training and implementation of SOPs.
Quality review of all PV SOPs.
Quality review of the Pharmacovigilance System Master File (PSMF).
Ensuring deviations are identified and the appropriate CAPAs are implemented.
Preparation of monthly report of pharmacovigilance activities.
Perform six monthly Quality check for individual case safety reports.
Perform quality review of regulatory documents (PSURs, RMP, ADCO, referrals and any other Health Authority requests etc).
Review of all PV trackers and folders.
Monitoring and auditing process of vendor and service provider.
Coordinate for Business Continuity plan.
Archiving of all PV related documents as per the SOP.
Qualification – D.Pharma/B.Pharma/ M. Pharma
Work Experience – Minimum 3 – 5 Years experience required. compulsory required candidate with PVQA experience.