Safety Physician - EMEA Lead

This vacancy has now expired. Please see similar roles below...

An exciting
home-based
role has arisen for a Safety Physician across Europe
to
ac
t
as
the EMEA lead. This is an amazing opportunity to combine your ex
perience with a well-established pharmaceutical
organisation
.

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 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
E
nsure up to date compliance in preparation to audits and regulatory authority inspections
Provide required support to the scientists
M
aintain 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
Leadership
Able to work independently
Soft skills (influencing, communicating)

To Apply

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 D
avid 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.

LI-

D
N
1

DrugSafety

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