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ICSR case processing || SPE/SME- Mumbai

Job Description - ICSR case processing || SPE/SME- Mumbai

 We're Hiring | Pharmacovigilance – Case Processing Associate & Quality Review (SME)

Join our growing Pharmacovigilance team! We're looking for experienced professionals with expertise in ICSR Case Processing and Quality Review.

Location: Mumbai, Maharashtra

We are hiring experienced professionals for the following positions:

1. Case Processing Associate (SPE)

Experience: 1–2 Years

Key Responsibilities:

  • ICSR case processing & data entry
  • Narrative writing / I-Narrative
  • Medical & product coding
  • Case routing, unblinding & closure
  • Self-QC and quality checks
  • USPI labelling

2. Quality Review Associate (SME)

Experience: 2+ Years

Key Responsibilities:

  • QC/Post-lock case review
  • Review of serious & fatal cases
  • Quality monitoring and error identification
  • Feedback to case processing teams
  • Support quality improvement initiatives


Requirements

1. Case Processing Associate (SPE):

  • Graduate/Postgraduate in Life Sciences, Pharmacy, Medical Sciences, or related fields
  • 1–2 years of Pharmacovigilance / ICSR Case Processing experience
  • Experience with Veeva Safety and/or Argus Safety
  • Good English communication skillls

    2. Quality Review Associate (SME): 

  • Graduate/Postgraduate in Life Sciences, Pharmacy, Medical Sciences, or related fields
  • 2+ years of Pharmacovigilance / Quality Review experience
  • Experience with Veeva Safety and/or Argus Safety
  • Strong analytical and communication skills

  • Benefits

    Career Growth Opportunities
    Exposure to Global Pharmacovigilance Processes


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