Senior Principal or Principal Pharmacovigilance Scientist
Company: Takeda Pharmaceuticals International GmbH
Posted on: February 25, 2021
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important to us. Due to the current situation related to the
Coronavirus (COVID-19), we're leveraging our digital capabilities
to ensure we can continue to recruit top talent at Takeda. As your
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recruitment process. Thank you. *Please be aware of an Identity
Theft Scheme targeting individuals seeking jobs with Takeda and
other employers. See below or here for more info. Senior Principal
or Principal Pharmacovigilance Scientist 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. Senior Principal or Principal
Pharmacovigilance Scientist Job ID R0030108 Date posted 02/04/2021
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
. 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 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 Senior Principal or a Principal
Pharmacovigilance Scientist in our Cambridge, MA office.
- Provides pharmacovigilance functional area expertise and
support to project teams for assigned developmental and/or marketed
- Responsible for operational pharmacovigilance activities for
assigned developmental and/or marketed products.
- Represent pharmacovigilance, both regionally and globally as an
authoritative and knowledgeable member of Global Clinical
Development Teams (GCDTs) and similar, commensurate with position's
- Closely involved in signal detection/safety monitoring
activities for pharmacovigilance operations with a lead
- Provide functional & therapeutic area expertise, supporting
less experienced colleagues and the safety effort more
- Flexible outside of primary therapeutic area as directed by
business and departmental need. ACCOUNTABILITIES:
- Technically fully competent to perform all usual Principal
Pharmacovigilance Scientist/Senior Pharmacovigilance Scientist
workload, including case report QC, review, follow-up and
reportability assessments and input into aggregate safety reports,
with the flexibility of mindset this requires.
- Liaise with other relevant functional areas both within and
outside of global PV to best ensure the most efficient and timely
attainment of compliant and patient focused safety data.
- Represent pharmacovigilance department in cross-functional
teams or committees and external environments at a global and
regional level as required, with the advanced communication skills
- In depth knowledge and understanding of designated
- Expect close interaction and involvement with senior PV
- Provide support and oversight of pharmacovigilance operational
activities for designated compounds.
- Lead set up of safety procedures for complex developmental
- Contribute to development of safety exchange agreements for
- Review and provide functional area expertise for development of
protocols, IBs, SAPs, CSRs and other relevant project/study
- Close knowledge of protocols to effectively respond to safety
- Participate in Global Safety Teams, coordinating all aspects of
signal detection/safety review activities.
- Draft responses to regulatory/ethics safety questions
- Close working relationship with physicians, both technically
- Perform ad hoc analyses e.g. in response to regulatory
- Integral to Global Safety Teams and associated support
- Other functions as directed by departmental and business
- Proficient in all communication skills, with the agility to
respond to different audiences in a clear and concise manner. Where
acting as the GSL can expect to lead presentations to Safety Board,
with the detailed preparatory work this implies and, where ad hoc
issues arise, the short timelines that can ensue. EDUCATION,
BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor's degree required. Advanced degree or specific
pharmacovigilance qualification preferred (MD, PhD, and
- 8+ years of related experience.
- Excellent databases and coding skills including ability to
perform advanced searches.
- In depth knowledge of clinical trial methodology,
pharmacovigilance regulations, safety profile and risk/benefit
- Critical thinking and decision making skills.
- Ability to review, analyze, interpret and present complex data
to a high standard.
- Global player in a global PV organization.
- Excellent communication and presentational skills.
- Good level of computer literacy.
- Excellent organization skills and ability to prioritize. 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 , Senior Principal or Principal Pharmacovigilance Scientist, Other , Cambridge, Massachusetts
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