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Employment Type:
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Posted:
8/11/2017
Job Category:
Science
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PV Scientist
Biogen | Cambridge, Massachusetts
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Job Description

External Posting TitlePV Scientist
Job DescriptionPV Scientists are responsible for assigned tasks for designated products or product groups. Reporting to a Sr. PV Scientist or above, the PV Scientist will serve as a critical team member with the lead PV Scientist (Sr. PV Scientist or Associate Director) for products or product groups, including performing signal management activities, authoring safety evaluations, contributing to aggregate report planning / authoring responding to ad hoc regulatory responses, conducting safety literature reviews, and serving on clinical trial safety teams. PV Scientist, with oversight from their manager, will serve as a Subject Matter Expert for the SABR and cross-functional team on relevant global safety regulations and guidelines; data output and analyses; and, product information.


•Collaborates on the preparation and authoring of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).

•Facilitates signal management process for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with SABR MDs and Sr. PV Scientist / AD, evaluates safety data and signals as part of ongoing pharmacovigilance activities. May include authoring signal evaluation reports, or sections of signal evaluation reports. Conducts literature review for safety information and interacts with other groups to obtain necessary data (i.e., Epidemiology, SAE data)..

•With Sr. PV Scientist / AD oversight, collaborates with Clinical Trial Physicians and Global Safety Officers on assigned investigational programs including protocol review, safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.
LocationCambridge, MA, US
Job CategoryDrug Safety
Requisition Number32254BR
Qualifications
• Minimum 5 years industry experience, with a minimum of 3 years of PV experience.

•Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).

•Interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues

•Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff.

•Applies clinical judgment to interpret case information.

•Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.

•Strong organizational skills, including the ability to prioritize independently with minimal supervision.

•Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
EducationBachelor's Degree in biologic or natural science; or health case discipline
Advanced degree (PhD, MPH, NP, PharmD, etc.) 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 "@biogen.com" email accounts.

About Biogen

Biogen Idec Inc. is engaged in the development, manufacturing, and commercialization of therapies. The Company's products address diseases such as multiple sclerosis, lymphoma and rheumatoid arthritis. The Company has four products: AVONEX (interferon beta-1a), RITUXAN (rituximab), TYSABRI (natalizumab) and FUMADERM (dimethylfumarate and monoethylfumarate salts). AVONEX is used in the treatment of relapsing forms of multiple sclerosis (MS). RITUXAN is used in the treatment of relapsed or refractory low-grade or follicular, CD20-positive, and B-cell, non-Hodgkin's lymphomas (B-cell NHLs). TYSABRI is approved for the treatment of relapsing forms of MS. FUMADERM acts as an immunomudulator. It also has product candidates, such as BG-12 (acquired with the purchase of Fumapharm), ANTI-CD80 antibody/(galiximab), ANTI-CD23 antibody/(lumiliximab), Ocrelizumab/(Humanized ANTI-CD20 Antibody) and Lixivaptan.In January 2007, the Company completed the acquisition of Syntonix Pharmaceuticals, Inc. (Source: 10-K)

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