Quality Auditor Pharmacovigilance Up To 7,00,0000 Salary p.m @ Intas
Quality Auditor Pharmacovigilance Up To 7,00,0000 Salary p.m @ Intas. Career @ Intas. M Pharma candidates are invited for job opportunity @ Intas. Check out all the details on the same below:
Job Title: Quality Auditor – Pharmacovigilance
Eligibility: M.Pharm (Pharmacology Preferred)
Salary: INR 2,50,000 – 7,00,000 P.A. Medical Insurance (self + 3 Family Member)
Key Responsibilities:
- Development, including review and sign off of new and existing company SOPs, oversight of control and issue of SOPs internally and to clients including affiliates as required.
- Contribute to the development of a robust mechanism for the issue of electronic SOPs.
- Management/facilitation of timely SOP training for staff and clients in relation to issue/effective date.
- Develop and manage a documented internal system (SOP) for formal approval, issue and control of company templates/forms to be accessible via a server
- To ensure that all SOPs/WIs/Guides are in accordance with relevant regulations and revised periodically to update the changes in legislation pertinent to Pharmacovigilance.
- Development of multiple-choice SOP questionnaires as part of SOP issue an acknowledgment of receipt to achieve documented competency testing
- Involvement in the development of customized document management system, with electronic signature functionality and related regulatory considerations.
Training:
- Ensures that all personnel of Lambda Therapeutic Limited are appropriately trained on the use of PV SOPs and that records of training are maintained.
- Ensures that each revision of any SOP is documented and additional training is provided on the updates.
- Oversees the design and implementation of training programs for pharmacovigilance.
- Co-ordination of training for team as per respective training SOPs.
- Monitor and manage the quality of documents produced by the department including the routine ICSRs, PSURs and SOPs to meet both internal SOP standards and external regulatory standards.
- Management of the monitoring of departmental compliance including the review of timely submission of Expedite reports, PSUR, Signal detection reports.
- To ensure that all pharmacovigilance activities are covered by appropriate SOPs, Work Instructions and Guides which fully explain the processes.
- Management and review of client / departmental Pharmacovigilance Management Plan (PMP) and Safety Data Exchange Agreements
Inspection/Audit Management:
- Support QPPV for Management of ongoing internal audit programme.
- Support QPPV for Management of vendor audits and External/Client Audits including scheduling, hosting and follow up of systems audits.
- Support QPPV for Management of Inspections.
