Associate Director, Pharmacovigilance (PV) Scientist
Company: Takeda Pharmaceuticals International GmbH
Posted on: February 25, 2021
The health and safety of our employees and candidates is very
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
application progresses, you may be asked to use one of our digital
tools to help you through your recruitment journey. If so, one of
our colleagues will explain how these tools will be used during the
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. Associate
Director, Pharmacovigilance (PV) 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. Associate Director, Pharmacovigilance
(PV) Scientist Job ID R0027296 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
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 an Associate Director,
Pharmacovigilance (PV) Scientist in our Cambridge, Massachusetts
office. Here, everyone matters and you will be a vital contributor
to our inspiring, bold mission. As an Associate Director,
Pharmacovigilance (PV) Scientist working on the Global Medical
Safety team, you will p rovide strategic leadership and safety
expertise, including support for regulatory submissions and
responses, aggregate reports, white papers, etc. A typical day will
- Expert from safety science perspective in primary therapeutic
- Potential Global Safety Lead for one compound
- Flexible outside of primary therapeutic area(s) as directed by
business and departmental need ACCOUNTABILITIES:--
- Serve as the Global Safety Lead
- Responsible for reviewing, analyzing, and interpreting
information from ongoing clinical and non-clinical studies
alongside the assessment of ensuing scientific and medical
implications of making recommendations based on new safety
information for both developmental compounds and marketed drugs to
ensure the primacy of patient safety
- PV science expert for designated compound(s) within primary
therapeutic as appropriate oversees safety and process activities
within these therapeutic areas.
- Integral to GST and GCDT and assisting with writing/reviewing
of aggregate reports including the RMP.
- Direct, mentor, and develop PV Science colleagues commensurate
with his/her experience.
- Ability to functions as senior contact for safety related
matters to cross functional groups and external bodies.
- Maintains compound and more general safety expertise
- Provides strategic and technical expertise and leadership. Sets
medical, scientific and process standards for all products within
these therapeutic areas.
- Contributes to clinical program and protocol design, safety
risk management, signal detection.--
- Oversees PV reports and submissions in designated therapeutic
area(s), e.g., aggregate reports and regulatory submissions.
- In collaboration with the PV TA Lead, leads evaluation and
management of emergent safety issues.
- Ensures adequate internal support and external resourcing (CRO
& BPO) to deliver all safety reports.
- Ensures adequate distribution of assignments and prioritization
of tasks within the PV specialist's staff.
- Interfaces with functional areas within and outside PV.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor's degree required. Advanced degree or specific
pharmacovigilance qualification preferred (MD, PhD, and
- Minimum 8 years experience in Pharmacovigilance with
significant experience in preparing regulatory documents.--
- Comprehensive understanding of PV process in aggregate
submissions and the new regulations that have been
- Demonstrated experience in people management and well-developed
skills in team building, motivating and developing people.
- Expert knowledge of clinical trial and pharmacovigilance
methodologies including safety profile and risk/benefit analysis
and detailed comprehension of global regulatory requirements
- Excellent organization skills and ability to prioritize
individual and team work loads.
- Excellent written and oral communication skills including
ability to present to large internal/external groups
- Capability to synthesize and analyze data from multiple
- Expertise in pre and post marketing SD.
- Demonstrated leadership skills with proven ability to motivate
and work in multidisciplinary teams. 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, Boston , Associate Director, Pharmacovigilance (PV) Scientist, Executive , Boston, Massachusetts
Didn't find what you're looking for? Search again!