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Pharmacovigilance Specialist

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Date: Jul 20, 2017

Location: Cambridge, MA, US

Company: Biogen

External Posting TitlePharmacovigilance Specialist
Job DescriptionPharmacovigilance Specialist supports the PV Scientist group by participating in signaling activities (managing documentation, supporting meeting logistics, etc.), supporting aggregate reporting (PSUR calendar, tracking global requirements (PSUR, RMP or REMS) / submissions, archiving documentation), supporting ad hoc regulatory responses (QC, archiving documents, logistical support), participating in QC of documents and other tasks as assigned. Supports review of literature through documentation archiving and maintenance. Assists with inspection readiness by ensuring documentation is complete and archived, maintaining archive sites, and conducting other activities as assigned.

• On the basis of data gathered by the Safety Surveillance & Aggregate Reports (SSA) group, maintains the PSUR / DSUR calendar, including regional requirements and assists the PV Scientists, SABR and cross-functional contributors in PSUR planning and execution. Contributes to PSUR metrics and KPIs.

• Assists PV Scientist team with logistical aspects of aggregate reporting (i.e., collecting data from contributors, archiving source documentation, document QC, etc.)

• Assists PV Scientist team with logistics for signal management (i.e., meeting minutes, QC of documentation, archiving of documentation, preparation for meetings)

• Support ad PV Scientist team with ad hoc regulatory responses (i.e. QC, archiving documentation, collecting data, etc.)

• Contributes to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions. Maintains SSA Sharenet site.
LocationCambridge, MA, US
Job CategoryDrug Safety
Requisition Number31417BR
QualificationsMinimum 6 months to one year industry experience, preferably pharmacovigilance experience.
EducationBachelor’s Degree in biologic or natural science. Advanced degree preferred
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.

One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.

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, Biology, R&D, Scientific, Science, Research, Engineering

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