Senior Medical Director, Drug Safety
Job Description Responsible for pharmacovigilance for all Biogen Idec marketed products. Responsible for oversight of the postmarketing safety group in Cambridge and RTP, for US and Canadian pharmacovigilance for all marketed products and for clinical development of marketed products, receipt and processing of adverse drug reactions from the market and SAEs from clinical trials of marketed products, analysis of safety data, and the identification and investigation of potential safety signals. The incumbent is also responsible for keeping management informed of safety issues and will work with clinical programs of marketed products as medical advisor. May represent Biogen Idec Drug Safety and Risk Management at internal and external meetings.
Location US-MA-Cambridge
Job Category Drug Safety
Requisition Number 20562BR
Qualifications Minimum of 7 - 10 years experience in Medical Research or Regulatory Affairs in the pharmaceutical/biopharmaceutical industry including significant management experience.
• Formal GCP training.
• Formal management training.
Preferred:
• Graduate training/experience resulting in board eligibility/certification and/or doctorate in basic/medical science.
• Postgraduate training in clinical epidemiology and biostatistics.
• Specialization and experience in gastroenterology/hepatology, nephrology, dermatology, neurology, intensive care, or clinical pharmacology.
• Formal management training/experience and demonstrated management skills.
Education • Graduate of recognized, accredited medical school
About Biogen Idec Biogen Idec (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers medicines to improve the lives of patients. As a company, Biogen Idec recognizes that cutting-edge science and medicines can address unmet patient needs to change the course of devastating diseases.
Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit every day from our industry-leading multiple sclerosis (MS) products. We have one of the strongest late-stage pipelines in the industry. In the coming years, we’re working hard to bring new therapies to market for patients with MS, amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s Disease), hemophilia, and others.
With more than 5,000 employees, Biogen Idec is a truly global organization – generating revenue of more than $5 billion worldwide in 2011. In addition to our headquarters in Weston, MA, and our research operations in Cambridge, MA, we have world-class manufacturing facilities in North Carolina and Hillerod, Denmark and offices in Canada, Australia, Japan and throughout Europe. We also have a direct commercial presence in 29 markets, including the US, EU, Brazil, China and India, and a network of distribution partners in more than 70 additional countries.