MCPHS University / Biogen - Safety and Benefit-Risk Management - Post PharmD Fellow
October 23, 2017
Fellowship - Entry Level
Biogen is responsible for the continuous assessment of the benefit-risk relationship of all of its products—starting in the early stages of development throughout the post-marketing phase. Members of the Safety and Benefit-Risk Management department are continuously working to gain better understanding of the safety profile of marketed products and those in development in order to provide the medical community and patients with the necessary data to make an informed decision regarding disease management.
This 2-year Safety and Benefit-Risk fellowship is designed to provide an in-depth and hands-on experience. Starting from individual case safety reports through aggregate reporting, the fellow will learn about the pharmacovigilance life cycle. Through this program, the fellow will gain exposure to the following three general areas:
Global Case Management: During this rotation, the fellow will become knowledgeable about the adverse event reporting process including initial review and triage, adverse event report assessment, and distribution rules. The fellow will also enhance his or her understanding of clinical trial safety, ICSR reporting, global pharmacovigilance regulations and guidelines, safety data exchange agreements, and vendor oversight.
Epidemiology: During this rotation, the fellow will work closely with epidemiologists to provide REMS support, understand and evaluate real-world data, and prepare epidemiology-based product summaries.
Pharmacovigilance (PV) Scientists: During this rotation, the fellow will engage in safety surveillance activities and prepare and review signal evaluations, periodic safety update reports, and risk management plans utilizing the training and skills gained through previous rotations.
The fellow will have the opportunity to spend up to 4 months in another department within Biogen.
Departments may include, but are not limited to:
Clinical Drug Supply Chain
Global Clinical Operations
Global Commercial Strategy
Applicants must hold a Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy at the commencement of the program.
Candidates must have excellent written and oral (ie, verbal) communication skills and a strong interest in pursuing a career within the biopharmaceutical industry.
The Biogen fellows will be selected on a nationally competitive basis.
All fellowships are for the duration of 2 years with a start date of July 1st.
In addition to your application via the ASHP Midyear Clinical Meeting Personnel Placement Service (PPS) here, please visit the MCPHS application portal to initiate your formal application http://www.mcphs.edu/pharmdfellow.
Biogen helped create an industry that has touched countless lives. We were among the world's first biotechnology companies, and today we are the oldest independent biotech firm in the world.From the start, when a group of scientists and venture capitalists were united by a new vision for serving unmet medical needs, the company's personality has reflected the multifaceted name of the industry we h...elped co-found: biotechnology. Biology is about life, about understanding the body's inner workings, about exploring new discoveries and insights to improve lives. Technology is about practical application, about making things work, about developing new products to help people. Biogen embodies both these worldviews. Scientific curiosity and courageous innovation helps us create new and important therapies; practicality makes us successful and vital to our patients. These values extend beyond our laboratories; our aim to discover better ways of doing things infuses all our work, from manufacturing and marketing to partnerships and human resources. At the same time, the practical application of our discoveries is what drives our scientists, as we seek treatments and therapies that can help patients live longer and better lives. At Biogen, we are proud of our more than 30 years of contributions to the biotechnology industry and look forward to continuing to shape the future of an industry that transforms scientific discovery into advances in patient care.