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

  • Position zu besetzen ab 13. Juli 2020
  • Permanent-ID OCR-FL-1030
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Tasks:
• Provide safety deliverables as per program timelines
• Provide safety strategic and hands (able to write) on input into submission documents such as Integrated Summary of Safety, Clinical Summary of Safety (Module 2.7.4), Clinical Overview (Module 2.5) as well when answering Regulatory requests
• 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
• 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:
– About 10 years of PV/drug safety experience
– Proven experience as safety submission lead
– Demonstrate safety strategy thinking
– Leadership
– Able to work independently
– Soft skills (influencing, communicating)

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