Leading Medical Safety Specialist
3 days ago
Job Title:
Medical Safety SpecialistLead a team of medical professionals in ensuring the safety and efficacy of medications.
Key Responsibilities:
- Develop and implement medical review plans to ensure compliance with regulatory requirements.
- Review adverse event reports and provide feedback on causality assessments.
- Collaborate with clients to understand their needs and expectations.
- Train and mentor junior medical reviewers.
- Participate in audits and inspections to ensure quality and compliance.
Requirements:
- MBBS or MD degree (Doctor of Medicine).
- At least 10 years of experience in leading medical review teams, client communications, and safety database management.
- Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
- Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment, and good medical knowledge and pharmacology understanding.
Technical Skills:
- Microsoft package.
- Working knowledge of EDC systems.
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