1. Effectively manages the drug safety function to ensure that safety reports received from clinical trials (and post-marketing) are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.
2. Provides medical expertise in the review and analysis of clinical study safety information.
3. Participates in the review of individual SAE reports, prepares medical commentary and analysis, and in the preparation of safety evaluations in aggregate periodic reports.
4. Ensures accurate medical coding (MedDRA and WHO-DD) of safety data.
5. Represents the Pharmacovigilance & Drug Safety department in safety-related discussions with clinical investigators, IRBs/ECs, Data Monitoring Committees and regulatory authorities.
6. Protects study subject safety by contributing to the ongoing risk/benefit analysis of investigational drugs in clinical development.
7. Prepares and maintains departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products.
8. Participates in health authority interactions (both written and verbal) and inspections regarding safety and risk management
9. Participates in due diligence to evaluate new potential in-licensing and out-licensing opportunities.
10.Provides supervision, leadership and professional development to members of the pharmacovigilance department.
1. M.D. (or equivalent), with at least 5 years relevant pharmaceutical industry experience in pharmacovigilance/drug safety.
2. Advanced knowledge of safety regulations, Good Clinical Practices, principles of drug development and safety assessment of investigational drugs.
3. Strong leadership and team management skills.
4. Excellent verbal and written communication skills, including formal presentation skills.
5. Experience in developing and implementing risk management strategies and plans.
6. Demonstrated experience in strategic and multi-project planning.
7. Excellent oral, listening, reading and written skills in English. Must be fluent in Mandarin.