Description: Global Safety Physician
***Remote until COVID restrictions are lifted**
Global Safety Physician
The Global Safety Therapeutic Areas serve as the safety experts for all company products globally and are accountable for the safety strategy and major safety deliverables for each company product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.
The Global Safety Physician (GSP) serves as the medical expert of the team to support the GSO in the conduct of quality safety assessment and risk management processes and activities for an assigned set of products through the product's life cycle. The GSP is responsible for the conduct of safety monitoring and accountable for executing all product related safety decisions and deliverables for assigned products as designated by GSO or TAH. Global Safety Officer may delegate to the Global Safety Physician where medical input is required.
The Global Safety Physician is responsible for the following:
- Directs the planning, preparation, writing and review of portions of aggregate reports
- Organize and direct liaison activities with affiliates and other internal partners regarding products
- Supports and provides oversight to staff with regards to safety in clinical trials.
- Review of AEs/SAEs from clinical trials as needed
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Participate in development of safety-related data collection forms for clinical studies
- Participate in study team meetings as requested or needed
- Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
- Documents work as required in the safety information management system
- Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body
- Assist GSO in the development of risk management strategy and activities.
Top 3 Must Have Skill Sets:
- Physician degree
- Prior global safety experience
- Bio/Pharma safety experience
