Safety Physician - EMEA Lead
An exciting home-based role has arisen for a Safety Physician across Europe to act as the EMEA lead. This is an amazing opportunity to combine your experience with a well-established pharmaceutical organisation.
- 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 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 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
- 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.
- 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 and Requirements
- 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)
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact David Nixon on +44 203 0789 544 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.