Medical Safety Lead

• Safety Monitoring: Oversee the clinical safety of projects/products, including literature reviews, individual case evaluations, and signal detection. Address safety-related queries promptly and appropriately.
• Medical Assessment: Conduct medical assessments for single cases, including follow-up information collection, evaluation of product quality defects with adverse events, and preparation of investigator notifications and ethics committee reports.
• Signal Detection: Identify and evaluate safety signals based on single cases and aggregate data using appropriate tools.
• Regulatory and Legal Support: Provide medical input for responses to regulatory inquiries, health care professionals, and legal queries. Prepare safety data for Health Authority review and contribute to safety documents.
• Documentation and Reporting: Assist in the preparation of safety documents such as core data sheets and clinical safety summaries. Contribute to the Safety Profiling Plan (SPP) and Risk Management Plan (RMP) updates.
• Cross-Functional Collaboration: Work with Clinical Development, Regulatory Affairs, Medical Affairs, and other departments to provide safety inputs for clinical and regulatory deliverables.
• Project Support: Support licensing activities, regulatory inspections, and project/product recall activities as needed.

Minimum Requirements

• Education: Bachelor s in Pharmacy, Nursing, PharmD, PhD, or Medical Degree (MBBS/MD) required. Specialization preferred.
• Experience: Minimum of 4 years in drug development, with at least 2 years in a patient safety role or equivalent experience. Experience in clinical trial methodology, regulatory requirements, and scientific methodology is desirable.
• Skills: Strong ability to analyze, interpret, and present safety information. Experience in preparing clinical safety assessments and regulatory reports.