Postdoctoral Research Fellow
Founded in 1898, Northeastern is a global research university and the recognized leader in experience-driven lifelong learning. Our world-renowned experiential approach empowers our students, faculty, alumni, and partners to create impact far beyond the confines of discipline, degree, and campus.
Our locationsin Boston; Charlotte, North Carolina; London; Portland, Maine; San Francisco; Seattle; Silicon Valley; Toronto; Vancouver; and the Massachusetts communities of Burlington and Nahantare nodes in our growing global university system. Through this network, we expand opportunities for flexible, student-centered learning and collaborative, solutions-focused research.
Northeastern's comprehensive array of undergraduate and graduate programs in a variety of on-campus and online formatslead to degrees through the doctorate in nine colleges and schools. Among these, we offer more than 195 multi-discipline majors and degrees designed to prepare students for purposeful lives and careers.
About the Opportunity:
Vertex Pharmaceuticals Incorporated
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. In addition to clinical development programs in cystic fibrosis (CF), Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other rare diseases.
Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.
At Vertex, we have some of the industry's best and brightest people helping us achieve our mission of discovering transformative medicines to help people with serious diseases. We depend on a talented global workforce to lead the charge as we work toward developing tomorrow's breakthrough medicines. The broad background possessed by a Pharm.D. graduate is highly valued in the Biopharmaceutical Industry, and certainly here at Vertex.
Global Patient Safety
Pharmacy Postdoctoral Fellow - Global Patient Safety (GPS) Post-Doctoral PharmD Fellowship with Vertex Pharmaceuticals & Northeastern University (2 Years)
The Global Patient Safety (GPS) Department provides pharmacovigilance expertise and risk management at all stages of drug development. As a member of the GPS Aggregate Reports and Risk Management Group, the fellow will work collaboratively and cross-functionally as a pharmacovigilance scientist to establish, surveille, and manage the safety profiles of investigational and approved medications. The fellow will also acquire a broader understanding of the role of GPS within Vertex through rotations with GPS Individual Case Safety Reports and GPS Epidemiology.
Aggregate Reports and Risk Management Primary Objectives
Gain an understanding of pharmacovigilance and how it is operationalized as aggregate safety reporting and risk management activities
Utilize clinical expertise to conduct ad hoc research into safety topics
Prepare aggregate safety reports (PBRER, PADER) and development risk management plans
Contribute to regulatory submissions (e.g., BLA, NDA, MAA, supplemental applications)
Support Disease Area Safety Teams to forward the clinical development of products in Phase 1 and Phase 2
Review international regulations to ensure compliance
Individual Case Safety Report Primary Objectives
Learn how safety information is collected in clinical studies, literature, and from post-marketing sources
Understand the safety information flow, standardization, and how their collection in the Global Safety Database impacts aggregate reporting and risk management activities
Epidemiology Primary Objectives
Understand the role of GPS Epidemiology in the clinical development of a product
Support post-authorization safety study reports
Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.
Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at the industry site and Northeastern.
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 1st , 2021:
- Curriculum vitae (CV), uploaded
- Unofficial PharmD transcripts, uploaded
- Cover letter, uploaded
Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 29th, 2021. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - Alnylam, GSK).
Address cover letter and three LORs to:
J. Andrew Orr-Skirvin, PharmD, BCOP
Clinical Professor, School of Pharmacy
Chair, Department of Pharmacy & Health System Sciences
Director of Pharmaceutical Industry Fellowship Program
360 Huntington Ave, 140TF R218
Boston, MA 02115
Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.
All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.
To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.
To apply, visit https://careers.pageuppeople.com/879/cw/en-us/job/507798