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 IC...