Safety Physician Consulting

* Provide safety deliverables as per program timelines
* Work in close collaboration with the Safety Strategy lead and other safety team members
* Deputize Safety Strategy lead at cross-functional teams for the product
* Provide an integrated assessment of safety signals and present own assessment to internal and cross-functional meetings
* Provide safety strategic and hands on input into periodic reports
* Responses to the EU Pharmacovigilance Risk Assessment Committee
* Initiate Post-Marketing Surveillance Plans
* Prepare documents to support regulatory authority meetings, interactions with external advisers or opinion leaders, collaboration with colleagues from partnership companies for co-development, or co-marketing
* Act as a safety subject-matter expert on medical safety within the team and with cross-function as required
* Ensure up to date compliance in preparation to audits and regulatory authority inspections
* Provide required support to the scientists
* Maintain a profound level of knowledge about the product and the therapeutic area (Oncology)

VORAUSSETZUNGEN:

Remote-part: 80%

* At least 10 years of PV / drug safety experience
* Proven experience as safety submission lead US / EU
* Leadership experience and mindset
* Able to work independently
* Demonstrate safety strategy thinking
* English business fluent, German nice to have