Your role:
The role of the Medical Director, Medical Safety TA Oncology is to ensure the delivery of integrated medical safety strategies for assigned development compound(s) and/or marketed product(s) including proactive safety surveillance and effective signal and benefit-risk management. The role includes the identification and evaluation of safety signals, the definition, implementation and evaluation of risk mitigation strategies, preparation of risk management plans, periodic safety reports, and other regulatory documents as well as the delivery of medical safety input to clinical development activities and submission dossiers.
Who you are:
* Physician with broad clinical experience
* Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred
* Several years of medical experience as a physician.
* Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience
* Mastery of global regulatory requirements for drug safety and pharmacovigilance
* Clinical knowledge of therapeutic area, patient populations and drug class
* Proficiency in signal detection and evaluation as well as benefit-risk management
* Strong Communication skills (written and oral presentations)
* Data analysis
* Scientific leadership
* Power of influence and persuasion