Principal or Sr Principal Pharmacovigilance (PV) Scientist, Global Medical Safety
Company: Takeda Pharmaceuticals International GmbH
Posted on: February 24, 2021
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other employers. See below or here for more info. Principal or Sr
Principal Pharmacovigilance (PV) Scientist, Global Medical Safety
Takeda fosters a collaborative and stimulating work environment
filled with opportunity and the chance to make a difference in
people's lives. It is a workplace driven by integrity, one of
Takeda's long-held values that extends to both the patients we
serve and our employees who develop and deliver medicines. Across
our company, Takeda employees bring together diverse strengths that
together create a stronger whole. As one of the world's leading
biopharmaceutical companies, Takeda is committed to bringing Better
Health and a Brighter future to people worldwide. We aspire to
bring our leadership in translating science into life-changing
medicines to the next level, in our core focus areas; oncology,
gastroenterology, neuroscience, rare diseases, plasma-derived
therapies, and vaccines. The Greater Boston Area is headquarters to
many of our Global and US business units. We are a passionate team
doing important work that impacts patients' lives. If you are
driven to create better health and a brighter future, join us!
Success What makes a successful member of our team? Check out the
traits we're looking for and see if you have the right mix. Life at
Takeda A Global Top Employer Recognized for our culture and way of
working, we're one of only select companies to receive Top Global
Employer -- status for 2021. Principal or Sr Principal
Pharmacovigilance (PV) Scientist, Global Medical Safety Job ID
R0031008 Date posted 02/16/2021 Location Boston, Massachusetts 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
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 company that will inspire you and support your
career? If so, be empowered to take charge of your future at
Takeda. Join us as a Principal or Senior Principal
Pharmacovigilance (PV) Scientist on our Global Medical Safety Team.
Here, everyone matters and you will be a vital contributor to our
inspiring, bold mission. As a Principal or Senior Principal
Pharmacovigilance (PV) Scientist working on the Global Medical
Safety team, you will p rovide core pharmacovigilance functional
area expertise and support to project teams for assigned
developmental and/or marketed products in conjunction with the
Global Safety Lead (GSL). a typical day will include:--
- Coordinates all aspects of signal detection and safety review
- 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. WHAT TAKEDA
CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- 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 Check out where you could be
working if you apply. Job Seekers: Protect yourself against
identity theft Please be aware there are instances of identity
thieves posting Takeda-branded jobs and posing as employees to
steal personal information. They visit job-related websites and
invite candidates to online chats. During the chat, they press job
seekers to provide bank account information and Social Security
numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited.
All rights reserved.
Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Principal or Sr Principal Pharmacovigilance (PV) Scientist, Global Medical Safety, Healthcare , Cambridge, Massachusetts
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