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Clinical Safety Consultant (M/F/D)
Consultant works closely with clinical safety physicians and assists aggregate report generation, signal identification and evaluation, in the specialty medicines therapeutic area for several marketed products in Europe.
Tasks:
Aggregate reports (i.e. PSUR/DSURs): Lead project management role of PSUR/DSUR preparation for several marketed products in Europe overseeing a vendor. This includes planning, , process oversight, and document management in the system with input from each product safety physicians.
Risk Management (Signal identification, evaluation, mitigation): Consults with safety physician in updating key documents such as Risk Management Plans (EU-RMP), Signal Detection/Assessment Reports, and assessing new signals.
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.
Qualification:
Bachelor’s degree at minimum required; Master or PhD with science background preferred.
Possesses strong medical or pharmacovigilance knowledge min 5 years
5 years of project experience with an advanced degree; 7 years of project experience with a Bachelor’s degree
Fluent business English (oral and written), German language skills desirable
Strong communication skill
Requirements:
Start: 01.06.2025
Duration: 12 months
Capacity: 5 days per week
Location: 100% remote
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