As a seasoned Clinical Leader, you will oversee the medical aspects of our drug safety initiatives.
Clinical Phase :
- You will lead a team as a medical monitor and provide expert guidance.
- Review study protocols and provide valuable feedback when necessary.
- Deliver comprehensive therapeutic area training to our case processing teams.
- Evaluate SUSAR reports for relevance.
- Analyze clinical data, ensure protocol compliance, and compile monthly reports for our clients.
Post-Marketing (Pharmacovigilance) :
Support the maintenance of our medical platform, including SOPs, manuals, and documents.Collaborate with our client's medical team and clinical team.Examine ICSRs and contribute to causality assessments, medical evaluations, and benefit-risk assessments.Mentor junior medical reviewers and conduct additional reviews to ensure their competency.Train and mentor other team members.Requirements : MBBS or MD degree. At least 10 years of experience in leading medical review teams. Strong pharmaceutical background and knowledge of GVP, GCP, FDA, and regulatory requirements.