An Astellas career offers a totally different way to work and live.

Astellas is the bright spot in the pharmaceutical industry – not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us!

Astellas is announcing a Medical Director/Senior Medical Director, Pharmacovigilance, Oncology opportunity at our Deerfield, IL location.

Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations. Additionally responsible for strategies in monitoring and analysis of cumulative safety information on Astellas products. Responsible for drug safety crisis management

Guides regulatory reporting including individual case safety reports (ICSRs), NDA annual report summary statements, and Periodic Safety Update Reports (PSURs)
Guides adverse event coding, retrieval and analysis activities in drug safety and clinical trials
Guides reviews of safety sections of NDA submissions
Plans cumulative safety information analysis such as signal detection from company or public databases with data mining
Guides safety updates of company core data sheet and local product labels
Guides pharmacoepidemiology projects
Guides crisis management on drug safety
Guides Risk Management Plans for specific products
Guides and coordinates preparation of ad-hoc benefit-risk assessment documents
Guides regulatory strategy and preparation of data related safety to regulatory authorities and advisory committees.
Interfaces with Medical Sciences, Clinical Studies, Product Safety Management, Drug Development and Project Management, Pharmacoepidemiology, Global Pharmacovigilance departments, Toxicologist, Biopharmaceutical sciences, Research Data Sciences, Legal
Timely identification of emerging safety issues. Management of emerging product risks.

Decisions regarding product safety and crisis management. Crisis management is a particularly important area that requires astute observational, analytical and managerial skills with a sense of urgency. Professional knowledge of clinical medicine is very essential to sort medical facts in problem analysis and decision analysis. Important decisions regarding product labeling need a risk/benefit analysis.

 

 
Position Requirements SUPERVISORY RESPONSIBILITY:
Directly supervises Assistant Medical Director(s), Associate Medical Director(s), and/or Medical Director(s) in the PSP Department.

KNOWLEDGE & EXPERIENCE: Identify specialized knowledge needed to perform the position. The years of experience are not required. Note if the specific knowledge or skill is required, desirable, or a plus.

MD degree, Pharmaceutical Industry experience in Pharmacovigilance and drug safety for at least five years, Team working, analytical skills, and flexibility are essential for this position.
 

 

Please visit us at www.us.astellas.com