Principal Pharmacovigilance (PV) Scientist, Global Medical Safety
Company: Takeda Pharmaceutical Company Ltd
Posted on: June 12, 2021
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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
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
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
- Coordinates and plays a critical role in the GPSE Safety Team
(GST) and Safety Management Team (SMT) for assigned compounds and
- 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
- 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
- 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
- Demonstrate strong knowledge of local and global health
- Support GPSE in the maintenance of a highly effective global
safety organization in full compliance to worldwide
- 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
- Excellent working understanding of safety database
configuration and adverse event coding to direct advanced
- In-depth knowledge of clinical trial methodology,
pharmacovigilance regulations, safety data analysis and
benefit-risk assessment, and understanding of drug
- Good critical/analytical thinking and project management
- 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
- Good level of computer literacy with commonly used software
(e.g., Microsoft Excel, PowerPoint, Word).
- Team player that performs effectively in a fast-paced,
- 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
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and
- 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
Keywords: Takeda Pharmaceutical Company Ltd, Boston , Principal Pharmacovigilance (PV) Scientist, Global Medical Safety, Other , Boston, Massachusetts
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