Lambda Therapeutic Research
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA.
Job Title: Quality Auditor – Pharmacovigilance
Salary: 4,00,000 – 6,00,000 P.A.
Oversight of overall PV-QA activities
Management of SOPs and Document Control:
- 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 development of a robust mechanism for 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 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 and acknowledgement of receipt to achieve documented competency testing.
- Involvement in development of customized document management system, with electronic signature functionality and related regulatory considerations.
- Management of Change Control.
- Review of Voids, Nullification and drug addition/deletion form
- 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.
- Managing and documentation of deviation
- Support Operation in improving quality of on-going process by implementing effective CAPA
- Inspection/audit Management
- Management of ongoing internal audit programmer.
- Management of vendor audits and External/Client Audits including scheduling, hosting and follow up of systems audits.
- Support QPPV for Management of Inspections.
- Quality Review of ICSR
- Quality Review of ICSR in Pv-Edge global safety database for completeness and correctness
- Preparation & review of Compliance Metrics.
- 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.
- Contract Management
- Management and review of client / departmental Pharmacovigilance Management Plan (PMP) and Safety Data Exchange Agreements
- QA Review of Validation documentation related to change control, URS, FS, IQ, OQ, PQ scripts, reports, protocol, and validation summary reports.