Drug Safety Physician

Job Description

The role requires in-depth knowledge of all Global Drug Safety processes relating to regulatory requirements e.g. for expedited reporting and periodic safety updates, to safety surveillance for the continuous assessment of the risk profile of assigned product(s), as well as to safety methodology within Clinical Development.

Also responsible for Drug Safety contribution to Periodic Safety Update Reports, Patient Risk Management Plans, Investigator Brochures, Clinical Trial Reports, and Common Technical Document (Integrated Summaries of Safety), etc.


Job Requirements:
The position demands and ability to give medical and clinical judgment, or to seek a specialist or expert advice if necessary, on a wide area of topics and therapeutic fields, both to personnel in-house, and to external clinicians and regulatory authorities. They must be highly motivated, with the innate ability to work under strict timelines, with strong leadership skills.

Experience:
•7-10 years Drug Safety experience
•MD

Technical Skills:
General Computer skills, Pharma/Biotech/CRO/Safety Systems skills a must.