Safety Scientist - Freelance - remote - #2096771

Safety Scientist - Freelance - remote

• 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

Duration: 1 year

Volume: 30-40h/week

remote

Haben Sie Interesse an diesem Projekt?

Dann freue ich mich auf Ihren Anruf unter +49 (0) 89 - 5519744 oder am besten gleich per E-Mail unter s.bloechl(at)progressive.de.

Herzliche Grüße aus München,

Stefan Blöchl