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Medical Patient Safety Physician
hace 7 días
What you will do:
Safety surveillance activities, including medical review of individual safety cases, safety signal detection and evaluation for your products, including collaboration with external safety teams.
Evaluate safety data from pre-clinical and clinical studies, medical literature and other information sources, to characterize the safety profile of the company medicines.
Build and develop clear, concise documents to describe your safety evaluation; for discussion with business partners and to support product labeling updates or responses to regulatory agency requests.
Representing Patient Safety on cross-functional teams, including the need to provide input to address urgent and important safety issues.
Provide patient safety contribution to global regulatory submissions for new medicines, formulations or indications.
Contributing to strategic Patient Safety input to drug development and post-marketing programs
Essential Requirements:
Medical degree (eg MD, MBBS)
At least 1 year of experience
Some clinical experience post-registration
Experience within the pharmaceutical industry, either in drug safety / PV or another relevant industry function
Intellectual curiosity and proven ability to learn new skills
Ability to contribute successfully to teams
Strong verbal and written communication skills
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