Drug Safety Physician (remote-based)

Hobson Prior are currently working with a global pharmaceutical organisation who are driven to help improve and prolong life. Our client is seeking a Drug Safety Physician to work remotely on a contract basis.
Job Responsibilities:

• Provide safety deliverables as per program timelines.
• Work in close collaboration with the Safety Strategy lead and other safety team members.
• Able to provide integrated assessment of safety signals. Able to present own assessment to internal and cross functional meetings.
• Able to deputize Safety Strategy lead at cross-functional teams for the product, including e.g. The Global Program Team.
• 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 (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.
• You will 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.

Key Skills:

• Demonstrate safety strategy thinking.
• Leadership.
• Able to work independently.
• Soft skills (influencing, communicating).

Requirements:

• At least 10 years of PV/drug safety experience.
• Proven experience as safety submission lead US/EU.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.