2023 Summer Internship - Marketed Products Development

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At Takeda, we are committed to lifelong learning.

To that end, 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 to start your career or further develop in your expertise.

The summer internship program is a full-time commitment of 12 weeks in length and offers a unique perspective into a world-class pharmaceutical company. Our internship program also provides you the opportunity to network with people at Takeda through various planned events and activities.

Learning Objective: Gain real-world, hands-on experience with understanding of the Regulatory context, framework, and compliance of Post Approval Safety Studies.

This position will be hybrid.

Under the oversight of the Post Marketing Safety Study Compliance Lead support:

• Compliance/Enhancement activities

  • Learn about Post authorization Safety Studies (PASS) Training program

  • Support Development and update for PASS procedural documents, forms, and templates

  • Support Audits/inspections and associated activities, as needed

  • Learn management of PASS quality events and analyze trending, if applicable

  • Support Pharmacovigilance System Master File (PSMF) review process

  • Perform QC of checklist for PASS and Post marketing surveillance studies (PMS)

  • Facilitate processes that support PASS identification

• Understand Regulatory context and framework for Post approval safety studies

  • GVP Module VIII – Post Authorization Safety Studies

  • GVP Module VI – Collection, management, and submission of reports of suspected adverse reactions to medicinal products

  • GVP Module V – Risk Management Systems

  • GVP Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators

  • PMS regulations (e.g. South Korea, China, Japan, India, Argentina)

• Meetings

  • Attend Center for Post Approval Safety Studies (CPASS) Team meetings

  • Meet with cross-functional subject matter experts in Medical QA, GPSE, EU QPPV, and other departments, as appropriate.

• Deadline-driven with a high level of organizational and planning skills

• Strong analytical, problem-solving, and oral and written communication skills

• Ability to work well in teams, effectively manage projects, and present ideas clearly and concisely.

• Global mindset to grow in a diverse work environment

• Excellent communication and leadership skills

• Good working knowledge of MS Office programs

As stated above, Takeda is committed to lifelong learning opportunities. To that end, our internship program is open to currently enrolled students seeking early experiences and non-traditional candidates interested in making a career change and gaining new experience.

The requirements for these two groups of candidates are specified below:

Candidates currently enrolled at an accredited university:

• Must be authorized to work in the US without sponsorship (i.e., Takeda will not sponsor interns)

• Must be available to work full-time (40 hours/week), within core business hours (8 AM-5 PM), for a minimum of 12 weeks during the summer months

• Minimum GPA 3.0/4.0

• Undergraduate, Graduate, PhD, MD student with at least one year of university studies before internship

• Return to university for at least one semester post-internship

• Takeda does not provide student housing or housing stipends

Non-traditional candidates not currently enrolled at university:

• Must be authorized to work in the US without sponsorship (i.e., Takeda will not sponsor interns)

• Must be available to work full-time (40 hours/week), within core business hours (8 AM-5 PM), for a minimum of 12 weeks during the summer months

• Must provide a cover letter explaining why you are seeking this internship, relevant experience that makes you a good candidate, and what you hope to achieve through the experience

  • Strong preference for non-traditional candidates with some experience relevant to the desired intern role

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.