Medical Reviewer

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...

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