Medical Safety Lead

3 weeks ago

Hyderabad, Telangana, India Thepharmadaily Full time
Job Description

- 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.

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