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Sr Associate II, Drug Safety Cambridge United States,  

Posted on : 18 May 2017

Project Description

External Posting TitleSr Associate II, Drug Safety Job DescriptionThe Senior Safety Associate is responsible for the evaluation and management of all incoming reports of adverse events of special interest (AESIs). The employee is responsible for the timely evaluation, review and follow-up related to AESIs in accordance with the regulations and Biogen procedures and conventions. Other key responsibilities include leading adjudication meeting and presenting clinical data on AESIs as well as representing the Safety and Benefit Risk Management on key company initiatives to advance the understanding of the safety profile of our products. The employee is also responsible for the training and oversight of external partners conducting case processing and follow-up activities on all AESIs and for overseeing certain regulatory commitments related to AESIs.1. Triage of all incoming initial and follow-up PML reports in RDC system2. Evaluation of the existing clinical data points and generation of relevant follow-up queries for all reports of AESI using, clinical knowledge, Pharmacovigilance experience, and communication skills:3. Collaboration with affiliate/distributor/and associated external AE collection partners for follow up queries in ROW locations 4. Direct administration of queries with healthcare providers in the US; additionally for US reports - provide established Biogen resources as needed5. Collaboration with US Biogen field staff (MSLs, ABMs) to gather relevant clinical dataCreation of AESI data collection tools LocationCambridge, MA, US Job CategoryDrug Safety Requisition Number31327BR Qualifications- 3+ years in a clinical setting (preferred but not required) - 2+ years in Drug Safety department in pharmaceutical / bio-pharmaceutical industry. EducationMinimum of Bachelor's level degree preferably in nursing, pharmacy, or other health related profession or alternatively a Bachelor's level degree in life sciences. About BiogenCorporate Overview Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer s disease, Parkinson s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options. Biogen was founded in 1978 and today serves patients in nearly 70 countries. A Fortune 500 company, Biogen in 2016 had revenues of $11.4 billion Global headquarters in Cambridge, MA, and international headquarters in Zug, Switzerland Our Science We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments. For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer s disease, Parkinson s disease, and ALS.As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders. Biogen is revolutionizing biologics manufacturing, developing the industry s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines. Our Corporate Citizenship The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. Please be advised that all legitimate correspondence from a Biogen employee will come from "" email accounts. Nearest Major Market: Cambridge Nearest Secondary Market: Boston Job Segment: Biotech, Pharmaceutical, Scientific, Risk Management, Science, Engineering, Research, Finance


Cambridge, MA, US

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