Job Description:

  • Preparing internal & external reports in response to adverse event information received by the Drug Safety and Pharmacovigilance Department
  •  

    Assist in ensuring ICSR readiness for inclusion in individual and aggregate reports (PSURs, PADERs, etc.)

  • Review adverse event information received for completeness and consistency, initiate case follow-up activities/AE query management, and independently generate narratives in accordance with department processes.
  • Perform quality control activities to ensure complete and accurate case information has been entered into the drug safety database.
  • Follow defined norms and Processes for case management and closure activities, Adhere to SOP of the company for communication and Documentations.
  • Ensure compliance with corporate and departmental standard operating procedures
  • Communicates product safety issues to team members in a timely manner.
  • Contributes to presentations, discussions, and data summaries on safety issues at meetings with external and internal partners.
  • Participate in audits and inspections as SME for global case processing.
  • Ensure Deviations and CAPAs are followed up on and closed in due time
  • Perform other activities as directed by Drug Safety and Pharmacovigilance management.

Qualification: B.Pharma/M.Pharma

Experience: 3-5 Yrs

Salary: Negotiable

Contact Details:

hr@mitoconbiopharma.com

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