Found 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...