Quality Auditor – Pharmacovigilance Vacant @ Lambda Therapeutic Research (Intas)

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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.

Job Description:

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
    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.

Deviation/CAPA Management:

  • 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
    Compliance monitoring
  • 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
  • Validation
  • QA Review of Validation documentation related to change control, URS, FS, IQ, OQ, PQ scripts, reports, protocol, and validation summary reports.

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