Posted: Monday, March 27, 2017 9:26 PM
External Posting TitleDrug Safety Physician
Job DescriptionResponsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post:marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit:risk profile for assigned compounds and products. Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor. May represent Biogen Safety and Benefit Risk Management at internal and external meetings. The successful candidate will demonstrate the flexibility and capability to function across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities.
1) Manage safety surveillance for assigned compounds / products
* Manage collection, in cooperation with a PV scientist, of current data for safety signaling and identify and investigate safety signals.
* Conduct analysis of safety data.
* Ensure adequacy of recording, summarizing, and handling of adverse events for investigational and/or marketed Biogen products including decisions on seriousness, expectedness, and causality.
2) Integrate the safety scientific component to build a strategic framework for clinical development plans.
3) Develop and maintain relationships with program counterparts in Clinical Development, Pre:Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Worldwide Medical.
Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities.
LocationCambridge, MA, US
Job CategoryDrug Safety
* Minimum 3 years' experience in the pharmaceutical industry, clinical care setting, or Academia.
* Industry experience in early clinical development is highly desirable.
* Benefit:risk related strategy experience required.
* Knowledge of clinical pharmacology and pre:clinical safety highly desirable.
* Demonstrated strategic and critical thinking.
* Excellent communication skills (oral and written) and excellent organizational skills.
* Capacity and willingness to work effectively across disease areas.
* The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
* Demonstrated ability to work in an entrepreneurial culture
EducationMD, or MD PhD, or MD MPH required; sub specialty training highly desirable
About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
Founded in 1978, Biogen is one of the world's oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer's Disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, spinal muscular atrophy and neuropathic pain amongst others.
With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world:class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 3
• Location: Boston
• Post ID: 38859838 boston