Senior Executive – Pharmacovigilance

Pharmazone

3 - 4 years

2 - 6 Lacs

ahmedabad

Posted:11 hours ago| Platform:

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Skills Required

medical writing solar energy pharmaceutical ich-gcp guidelines pv drug safety clinical data management solar pharmacovigilance ich renewable energy psur case processing clinical research compliance quality assurance argus meddra clinical trials

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 new 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

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