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Manager - Global Pharmacovigilance

3-4 years years
Preffered by Company
Not Disclosed July 10, 2024
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD Skills: Causality Assessment, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Title: Manager - Global Pharmacovigilance


Date: July 9, 2024
Location: Sun House - Corporate Office, Mumbai
Company: Sun Pharmaceutical Industries Ltd

Job Description:

Responsibilities:

  1. Adverse Drug Reaction (ADR) Processing:

    • Data Entry/Case processing of ADR cases in Argus Safety Database ensuring compliance as per applicable SOPs.
    • Review of Literature Alerts and Individual Case Safety Report (ICSR) Information.
    • Perform Reconciliation of applicable ADR case tracker(s) to ensure compliance as per applicable SOPs.
    • Clinical Trial ADR case processing as per applicable procedural documents.
    • Update ADR case workload tracker(s) for assigned regions.
  2. ADR Case Triage and Validity Assessment:

    • Perform triage of ADR cases for seriousness/follow-up significance and identification of suspect products and events.
    • Perform ADR case validity assessment.
  3. Other Pharmacovigilance Projects:

    • Work in any other assigned Pharmacovigilance project.
    • Ensure compliance to applicable SOPs.
    • Maintenance of personal Pharmacovigilance records as per the applicable SOP.

Skills:

  • Good communication skills.
  • Awareness of global drug safety guidelines.
  • Medical knowledge.

Qualification:

  • M. Pharm, BDS.

Experience:

  • Minimum of 3-4 years in processing and handling of ICSRs preferred.
  • Candidates with less experience but with good academic excellence can also apply.