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Employment Type:
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Posted:
8/14/2017
Job Category:
Science
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Drug Safety Physician
Biogen | Cambridge, Massachusetts
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Job Description

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 Drug Safety and Risk Management at internal and external meetings. The MD can be appointed as the Global Safety Officer for a specific compound / product.
The successful candidate will demonstrate the flexibility and capability to function at a high level 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
a. Manage collection, in cooperation with a PV scientist, of current data for safety signaling and identify and investigate safety signals.
b. Conduct analysis of safety data.
c. 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. Provide safety strategic leadership for clinical development programs / program teams
a. 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, Quantitative Sciences, Translational Sciences, Worldwide Medical.
4. Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.
5. If applicable, manage Medical Director(s) and Associate Medical Director(s) overseeing their activities for assigned compounds / products.
LocationCambridge, MA, US
Job CategoryDrug Safety
Requisition Number31199BR
Qualifications
• Minimum 5 years experience in the pharmaceutical industry or clinical care setting.

• Preferably has prior experience in clinical development or drug safety.

• Knowledge of pre- and post- marketing US and EU regulations

• Knowledge of clinical pharmacology 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 sense of urgency and accountability for both individual and team-owned work products.

• 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 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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