Skip to main content

Search Our Jobs

Sr Pharmacovigilance Principal Scientist

Boston, Massachusetts

Overview

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!

Back to Job Navigation (Overview)

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.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

Back to Job Navigation (Success)

Back to Job Navigation (Life at Takeda)

Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

Back to Job Navigation (Rewards)

Sr Pharmacovigilance Principal Scientist

Apply Now
Job ID R0021760 Date posted 08/11/2020 Location Boston, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice, Privacy Policy and Terms of Use.

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 PV Principal Scientist in our Cambridge, MA office.

OBJECTIVE: 

  • 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 generally 
  • 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 requires.  
  • 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 skills.
  • 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 this requires.
  • 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 the department.
  • Conduct project activities for designated developmental products:
  • Lead set up of safety procedures for complex developmental programs
    • Contribute to development of safety exchange agreements for co-development projects
    • Review and provide functional area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents
    • Close knowledge of protocols to effectively respond to safety issues.
    • Providing investigator and monitor training on safety procedures
    • 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 Plan
    • Assist with set-up and running of DSMBs
    • Close working relationship with physicians, both technically and managerially
    • Perform ad hoc analyses e.g. in response to regulatory queries
    • Integral to Global Safety Teams and associated support
    • Other functions as directed by departmental and business needs
  • 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 PharmD).
  • 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 analysis.
  • 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 prioritize
  • Bachelors with minimum 20 years of experience in healthcare, clinical or pharmacovigilance related environment
  • Masters with minimum 15 years of experience in healthcare, clinical or pharmacovigilance related environment
  • PhD with minimum 9 years of experience in healthcare, clinical or pharmacovigilance related environment

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • 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.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

#LI-MT1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0021760

Apply Now

Back to Job Navigation (Responsibilities)

Explore the Area

Check out where you could be
working if you apply.

View Map