Postdoctoral Research Fellow, Vertex Pharmaceuticals Incorporated, Global Patient Safety

Postdoctoral Research Fellow, Vertex Pharmaceuticals Incorporated, Global Patient Safety

About the Opportunity

Job Summary:

The Northeastern University Fellowship Program provides a dynamic academic environment offering fellows the opportunity for a wide breadth of experiences:

• Develop teaching skills through participation in our Teaching and Learning Seminar series
• Facilitate small and large group didactic education in partnership with a faculty mentor
• Utilize a layered learning model in experiential education by co-precepting students on pharmacy practice experiences including Northeastern's unique co-op program
• Create, present, and publish scholarly research through collaborative industry and university relationships
• Engage with faculty who participate in various interdisciplinary graduate programs including biotechnology, nanomedicine, immunology, health informatics, and drug discovery
• Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees

Vertex Pharmaceuticals Incorporated

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of cell and genetic therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America.

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.

Responsibilities:

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

Qualifications:

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 Vertex and Northeastern.

Additional Information:
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31st , 2022:

• 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 28th 2022. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - Vertex).

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

Position Type

Research

Additional Information

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://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/Boston-MA-Main-Campus/Postdoctoral-Research-Fellow--Vertex-Pharmaceuticals-Incorporated--Global-Patient-Safety_R108847



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