Beschreibung
Clinical Safety Consultant with scientific background (m/w/d)Consultant works closely with clinical safety physicians and assist signal identification, evaluation, and risk mitigation across therapeutic areas for several marketed products in EU. Consultant works with global CSPV staff (in US/Japan) and other functions (Medical Affairs, Regulatory Affairs).
Tasks:
- Aggregate reports (i.e. PSUR): Lead project management role of PSUR preparation for several marketed products in EU. This includes planning, information collection, project related meeting organisation, process driving, outlining the documents (authoring support) and document management in the system with input from each product safety physicians.
- Risk Management (Signal identification, evaluation, mitigation): Is a key participant in developing, and possibly implementing, the risk management strategy for assigned products. Demonstrates familiarity with PV/Epi related literature. Consults CS physician in developing key documents such as Risk Management Plans (EU-RMP), Signal Detection/Assessment Reports, and assessing new signals. May independently integrate and analyse safety data from multiple sources to deliver comprehensive conclusions.
- Safety Communication: Develops strategy for communicating safety information internally and externally (including EU Risk Minimisation Activities) with product safety physicians. May first author safety communications and take responsibilities of its implementation working with EU affiliates' Local Safety Officers.
- Documentation/Tracking: Documents meeting discussions, decisions and action items independently. Ensures the appropriate archiving of the team meeting documentation and signal management activities independently. This includes the maintenance of safety signal tracking in the system.
- Project Management: Serves as a project manager for safety topics related to signal management and aggregate report and ensures adherence to project timeline.