Assistant Pharmacovigilance Manager

22 hours ago


Mumbai Mumbai Suburban Navi Mumbai, India Cipla Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Description:

  • Receipt of cases and their assessment to ensure the information is adequate to qualify the case as ICSR.
  • Perform data entry of ICSR by assessing the source documents and ensure the information entered in the Argus database is appropriate as per source documents of the complaint received.
  • Follow up for the information of potential cases as per SOPs if the initial information is inadequate
  • To review cases processed by the case processors for quality, MedDRA coding, narrative, and overall consistency with source documents, SOPs.
  • To provide periodic quality improvement feedback to case processor.
  • To identify areas of improvement in terms of compliance, quality, and productivity.
  • To escalate instances of repeated case processing errors and non-compliance.
  • To ensure that regulatory reports are approved and submitted to partners or regulatory authority in appropriate format and within the appropriate timelines.
  • To ensure that source documents pertaining to regulatory authoritys acknowledgement of ICSRs are archived in Argus.
  • To ensure on time escalation of IT related issues pertaining to Argus and Axway
  • Handling of CAPA, Deviation, CR and QMS related activities
  • Assisting the case reporting team in preparing of covering letters for manual submission of reports
  • Seeking of Regulatory status and other relevant approvals.
  • Confirming of batch no details for Cipla Products through SAP System.
  • To allocate and review the cases for reporting assessment.
  • Provide product configuration requests for Argus.
  • To provide support in preparation of Safety Management Plan as required.
  • Preparation and review of SOPs as applicable.
  • Complete sign off activity for new reporting associates and documentation as applicable.
  • Any other task/assignment by department head/section head.
  • To perform monthly TGA DAEN activity.
  • To perform the role of a subject matter expert (SME) for all ICSR and reporting related related activities
  • Complete sign off activity for new Book-in, DE and QR associates and documentation applicable.
  • Responsible for ensuring submission of cases to Regulatory Authorities within timelines
  • Respond to reporting queries raised by vendors within timelines.
  • Analyze performance of the team members and vendor periodically and provide feedback to ensure compliance with organizational SOPs.
  • To perform compliance manager activities for various countries in EY tool


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