• Provide safety deliverables as per program timelines.
• Work in close collaboration with the Safety Strategy lead and other safety team members
• Able to deputize Safety Strategy lead at cross-functional teams for the product, including e.g. the Global Program Team (GPT)
• Able to provide integrated assessment of safety signals. Able to present own assessment to internal and cross functional meetings
• Provide safety strategic and hands (able to write) on input into periodic reports (PSUR/PBRERs/ CO..). Responses to the EU Pharmacovigilance Risk Assessment Committee (PRAC)
• Initiate Post-Marketing Surveillance Plan
• Prepare documents to support (reports, slides… ) regulatory authority meetings, interactions with external advisers or opinion leaders, collaboration with colleagues from partnership companies for co-development or co-marketing.
• Able to 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
• At least 10 years of PV/drug safety experience
• Proven experience as safety submission lead US/EU
• Demonstrate safety strategy thinking
• Able to work independently
• Soft skills (influencing, communicating)