Our global Pharmacovigilance (Patient Safety) unit is hiring an excellent physician to join the Medical Scientific Unit. In this unit, we lead drug safety across the entire company portfolio and throughout the product lifecycle.
In partnership with other stakeholders, our MSU safety physicians continuously identify and define risks of our drugs and propose measures to manage or mitigate them. In this way, we maximize the benefit-risk ratio of our drugs and provide comprehensive safety information to patients, prescribers and regulators.
The job includes:
Assessment of benefit risk information
Medical evaluation of Individual Case Safety Reports (ICSR) and
Evaluation of safety signals
Formulation of responses to regulatory inquiries
Preparation and contribution to regulatory documents
Participation in FDA advisory committees
Close work with many interfaces, both in the company (Medical Affairs, Clinical Development, QA etc) and outside (KOLs, Universities etc)
Participation in labelling review and revision;
Supporting legal department in safety related issues
Other duties as assigned or as business needs require.
MD with valid Israeli license
Board eligible/certified or equivalent residency or subspecialty training
Epidemiology degree and/or training- An advantage
1 year of clinical practice experience – an advantage
Full time position in our Netanya offices