Scientific Director
3 weeks ago
Job Summary
This position supports the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. The successful candidate will provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets, ensuring scientifically sound review and interpretation of data and management of safety issues.
Key Responsibilities
- Provides medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
- Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate.
- Makes recommendations for the further characterization, management, and communication of safety risks.
Requirements
- Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Advanced degree preferred.
- Substantial experience in pharmacovigilance or drug development.
- Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
- Experience working in large matrix organizations.
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