
Senior Medical Reviewer Lead
8 hours ago
We are seeking a seasoned medical expert to lead our team as a senior medical reviewer.
Clinical Phase:
- Lead medical monitoring activities, including protocol review, therapeutic area training, and adverse event management.
- Develop and implement effective communication strategies with clients, sites, and internal stakeholders.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements, such as GCP and GVP.
Post-Marketing (Pharmacovigilance):
- Serve as the primary point of contact for client concerns and escalations.
- Provide medical review of ICSRs, including causality assessment and benefit-risk evaluation.
- Mentor junior medical reviewers and perform additional reviews to ensure competency.
Key Requirements:
- MBBS or MD degree.
- Minimum 10 years of experience in leading medical review teams, with at least 5-7 years in clinical phase.
- Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
Desirable Skills:
- Microsoft package proficiency.
- Working knowledge of EDC systems.
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