Senior Principal Pharmacovigilance Scientist
Company: Takeda Pharmaceuticals International GmbH
Posted on: January 12, 2021
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Theft Scheme targeting individuals seeking jobs with Takeda and
other employers. See below or here for more info. Senior 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 2020. Senior Principal
Pharmacovigilance Scientist Job ID R0024336 Date posted 10/26/2020
Location Boston, Massachusetts 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 Pharmacovigilance Scientist
in our Cambridge, MA office. Primary responsibilities include but
are not limited to:
- Provides pharmacovigilance functional area expertise and
support to project teams for assigned developmental and/or marketed
products. As appropriate and exceptionally, may be the lead safety
support for a compound as the Global Safety Lead (GSL).
- 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
seniority/experience and particularly when the designated GSL.
- Closely involved in signal detection/safety monitoring
activities for pharmacovigilance operations with a lead
responsibility if the designated GSL.
- 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 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
- The attainment of advanced compound expertise might, for
exceptional individuals, allow for Global Safety Lead (GSL)
responsibilities where the individual has demonstrated both the
requisite depth of knowledge and associated advanced communication
- 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
products/studies. If the responsible GSL, will be seen as the
company's lead responder and source of expertise for safety related
issues for designated compound.
- Expect close interaction and involvement with senior PV
physicians and the safety Therapeutic Area Lead (TAL), particularly
when the responsible GSL.
- Provide support and oversight of pharmacovigilance operational
activities for designated compounds, with lead responsibilities
when acting as the GSL
- Mentorship and guidance for less experienced colleagues within
- 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
- Providing investigator and monitor training on safety
- Participate in Global Safety Teams, coordinating all aspects of
signal detection/safety review activities.
- Draft responses to regulatory/ethics safety questions
- Assist with writing and maintenance of the Safety Monitoring
- Assist with set-up and running of DSMBs
- 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,
BEHAVIOURAL 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, analyse, interpret and present complex data
to a high standard.
- Global player in a global PV organisation.
- Excellent communication and presentational skills.
- Good level of computer literacy.
- Excellent organisation skills and ability to prioritise. 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 Pharmacovigilance Scientist, Other , Cambridge, Massachusetts
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