2021 Summer Internship - Post Marketing Safety at Shire Human Genetic Therapies, Inc. in Boston, Massachusetts

Job Description:

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice, Privacy Policy and Terms of Use.

Job Description

POSITION OBJECTIVES:

Takeda's summer internship program blends real world experience with an extensive overview of the pharmaceutical industry. Knowledgeable mentors will provide guidance as you gain professional hands-on experience. The summer internship program is 12 weeks in length and offers a unique perspective into a world-class pharmaceutical company. Compensation is competitive, and financed temporary housing is available to those who qualify. Our internship program also provides you the opportunity to network with people at Takeda through various planned events and activities.

POSITION ACCOUNTABILITIES:

Learning Objective: Gain understanding of the Regulatory context and framework for Post Marketing Safety Studies.

Under the oversight of the Post Marketing Safety Study Lead:

• Review and understand the regulatory guidelines for Post Marketing Safety Studies
  
  
  • Post Authorization Safety Studies ((PASS); GVP Module VIII, FDA guidelines)
  
  
  • Post Marketing Surveillance Studies ((PMS); South Korea, China, Japan, India, Mexico, Argentina)
  
  
  
  


• Understand and define PASS and PMS
  
  
  • Review Takeda PASS and PMS procedural documents
  
  
  • Review protocols and study reports to gain understanding of the different types of Post Marketing Safety studies, as appropriate
  
  
  
  


• Develop PowerPoint presentation: Post Authorization Safety Studies: EU vs Rest of World approach (comparing perspectives, requirements and recommendations)


• Global tracking of Post Marketing Safety Studies and archiving of documents:
  
  
  • Ensure all PASS and PMS study data are standardized to the greatest degree possible in the Takeda Clinical Trial Management Systems
  
  
  • Archive PMS and PASS study documents into the Electronic Document Management Systems (EDMS)
  
  
  
  


• Attend weekly PMS Team meetings and other cross-functional team meetings, as appropriate


• Ad Hoc Team Support: support audits/inspection activities as needed, formatting and other logistical tasks

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Applicants must be enrolled in a U.S. accredited university for the semester before and immediately following the internship.


• Applicants must be pursuing a graduate in a Science or Healthcare related discipline (e.g. Nursing, Pharmacy, Public Health)


• Must be deadline driven and have a high level of organizational and planning skills


• The ideal candidate exhibits strong analytical, problem-solving, and oral and written communication skills; he or she also possesses the ability to work well in teams, effectively manage multiple projects, and present ideas clearly and concisely.


• Experience in each of the following MS Office applications:


• MS Outlook - Proficient


• MS Word – Proficient


• MS Excel – Proficient


• MS PowerPoint - Proficient

Better Health, Brighter Future

Learn more at takedajobs.com.

About Takeda Pharmaceuticals

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do.

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan. Takeda core focus areas are gastroenterology, neuroscience, rare diseases, plasma-derived therapies, vaccines, and oncology, in which we seek to bring further innovation in these areas through a robust development pipeline. Our mission is simple and compelling: we are committed to strive toward better health for people worldwide through leading innovation in medicine. Our commitment to improving health and supporting our employees, partners and the larger community gives us the purpose to build on the tremendous success we enjoy as an emerging global leader in the pharmaceutical industry.

Intern pay rate ranges are from $18/hour to $45/hour, depending on students level in their undergraduate or graduate program and level professional experience.

Locations

Worker Type

Worker Sub-Type

Time Type

Full time