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    • Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.
    • Make assessments on SUSAR reportability.
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  • JOB TIME 12PM TO 8PM MOBILE NO - 9898060384 JOB LOCATION - -PALDI EDUCATION - BHMS - BAMS Pay: ₹35,000.00 - ₹45,000.00 per month Benefits: * Flexible…
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Job Post Details

Medical Reviewer - job post

ProductLife Group
3.2 out of 5 stars
Remote
You must create an Indeed account before continuing to the company website to apply

Job details

Job type

  • Contractual / Temporary
  • Permanent

Full job description

ProductLife Group is looking for Medical Reviewers having minimum 5 years of experience in Pharmacovigilance Medical Reviewing.

Responsibilities:

Clinical Phase:

  • Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation).
  • Make assessments on SUSAR reportability.
  • Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required).
  • Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.

Post-Marketing (Pharmacovigilance)

  • Support in maintenance of medical platform including SOPs, manual and documents.
  • Interaction with the clients medical team and clinical team
  • Medical review of the ICSRs (e.g., Spontaneous, literature)
  • Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.
  • Provide feedback and ongoing workshops to develop the medical reviewers.
  • Participate in audits and inspections as required
  • Ensure understanding of client needs, conventions and ensure expectations are met and exceeded

Required Education:

MBBS, or MD (Doctor of Medicine)

Required Experience:

  • Client communications
  • Safety Database experience
  • Minimum 5 years experience working for service providers or pharmaceutical company.

Required technical skills:

  • Microsoft package
  • Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
  • Working knowledge of EDC systems
  • Good Medical knowledge and Pharmacology understanding

Additional experience and/or skills:

  • Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.
  • Experience with DSMB preferred.
  • Ability to deliver constructive feedback
  • Emotional intelligence
  • Adaptability
  • Analytical skills
  • Flexibility
  • Reliable
  • Strong organisation skills
  • Punctual
  • Database experience
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