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Principal Pharmacovigilance (PV) Scientist, Global Medical Safety

Company: Takeda Pharmaceutical Company Ltd
Location: Boston
Posted on: June 12, 2021

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Principal Pharmacovigilance (PV) Scientist, Global Medical Safety, in our Cambridge, Massachusetts office or have the opportunity to work remote.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Principal Pharmacovigilance (PV) Scientist, Global Medical Safety, working on the GPSE Safety Oncology team, you will be empowered to coordinate all aspects of signal detection and safety review activities. A typical day will include:

  • Supports GSL in overseeing the medical safety profile for assigned products.
  • Coordinates and plays a critical role in the GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products.
  • Provides functional and therapeutic area expertise in helping to manage the cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.

ACCOUNTABILITIES:

  • Facilitate ongoing safety surveillance for assigned products, assisting with data collection and assessment for GST and SMT.
  • Coordinate and perform signal identification, evaluation and management activities for assigned products.
  • Assist with authoring safety evaluations, defining scope and methodology and providing background information for aggregate safety reports, conducting preliminary safety analyses, and preparing ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses.
  • Partner with cross-functional colleagues of the SMT and contribute to safety-related deliverables associated with new drug applications, benefit-risk assessments and activities related to risk minimization including RMPs.
  • Liaise with colleagues in relevant functional areas within and outside of GPSE to gather and provide input for appropriate sections of critical documents (e.g., protocols and amendments, ICFs, IBs, core data sheets, IMPDs, CSRs, INDs, NDAs, BLAs, and CTAs).
  • Assist with the preparation of presentation of identified and potential patient safety risks and SMT recommendations on safety issues to cross-functional decision-making bodies such as the Takeda Safety Board.
  • Build and maintain in-depth knowledge and understanding of designated products/studies, and close knowledge of protocols to effectively respond to safety issues.
  • Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents.
  • Demonstrate strong knowledge of local and global health authority requirements.
  • Support GPSE in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations.
  • Train and mentor newly hired peers and Lead PV Scientists.
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and foster a community of continual learning.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent qualification; advanced degree in scientific or medical field preferred.
  • Minimum 5 years of relevant biotech/pharmaceutical experience.
  • Excellent working understanding of safety database configuration and adverse event coding to direct advanced searches.
  • In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis and benefit-risk assessment, and understanding of drug development.
  • Good critical/analytical thinking and project management skills.
  • Ability to review, analyze, interpret and present complex data to a high standard, with keen attention to detail.
  • Competency in oral and written communications and presentations.
  • Good level of computer literacy with commonly used software (e.g., Microsoft Excel, PowerPoint, Word).
  • Team player that performs effectively in a fast-paced, cross-functional environment.
  • Excellent organization skills and ability to prioritize independently (with minimal supervision).
  • Ability to coordinate, moderate, and clearly document conclusions of cross-functional scientific meetings.

This job posting excludes CO applicants

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com

#LI-NS1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Keywords: Takeda Pharmaceutical Company Ltd, Boston , Principal Pharmacovigilance (PV) Scientist, Global Medical Safety, Other , Boston, Massachusetts

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