Drug safety expert (PSUR/PRAC) (m/f/n) – Freelance – on hold

  • Position zu besetzen ab 13. Juli 2020
  • Permanent-ID OCR-FL-1032
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Task
• 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

 

Skills
• At least 10 years of PV/drug safety experience
• Proven experience as safety submission lead US/EU
• Demonstrate safety strategy thinking
• Leadership
• Able to work independently
• Soft skills (influencing, communicating)

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