Takeda Digital Ventures
Senior Principal Pharmacovigilance Scientist
Takeda Digital Ventures, Oklahoma City, Oklahoma, United States
Senior Principal Pharmacovigilance Scientist
Join to apply for the
Senior Principal Pharmacovigilance Scientist
role at
Takeda Digital Ventures Senior Principal Pharmacovigilance Scientist
3 weeks ago Be among the first 25 applicants Join to apply for the
Senior Principal Pharmacovigilance Scientist
role at
Takeda Digital Ventures Job Level: Senior Travel: Minimal (if any)
Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.
In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.
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Job ID
R0157855
Date posted
07/11/2025
Location
Remote
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 with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a
Senior
Principal Pharmacovigilance Scientist
where you will provide pharmacovigilance functional area expertise to project teams for assigned developmental and marketed products and be responsible for operational pharmacovigilance activities for assigned developmental and marketed products. You will represent pharmacovigilance, both regionally and globally as an authoritative and knowledgeable member of Global Clinical Development Teams (GCDTs) and similar, determined by the position's seniority/experience. You will also be involved in signal detection/safety monitoring activities for pharmacovigilance operations with a lead responsibility. As part of the GPSE Global Medical Safety team, you will report to the Senior Medical Director, GI and work with the broader safety cross-functional groups.
How You Will Contribute
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 timelyattainment of compliant and patient-focused safety data. Represent the 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-depthknowledge and understanding of designated products/studies. Expect close interaction and involvement with senior PV physicians. Provide support and oversight of pharmacovigilance operational activities for designated compounds. Conduct project activities for designated developmental products. Lead set up of safety procedures for complex developmental programs. Contribute to the development of safety exchange agreements for co-development projects. Review and provide functional area expertise for the development of protocols, IBs, SAPs, CSRs, and other relevant project/study documents. Close knowledge of protocols to effectively respond to safety issues. 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 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.
Minimum Requirements/Qualifications
Bachelor's degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, Ph.D., and PharmD). 6+ years of related experience required. Prior experience must include: Conducting safety signal detection, assessment, and management from various sources including medical scientific literature and global safety database (2 years); performing the medical assessment of the individual case and aggregate safety reports for product safety profile and addressing safety -elated regulatory authority requests (2 years); apply clinical trial methodology, various regulatory submissions, pharmacovigilance regulations, and safety profile to perform risk/benefit analysis (risk management plan) (2 years); utilize proficient communication skills with the ability to review, analyze, interpret and present complex safety data to a high standard during internal and global cross-functional collaborations for patient safety (2 years). Excellent databases skills and detailed understanding of MedDRA codes including the 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, analyze, interpret, and present complex data to a high standard. Advanced computer skills with the ability to work within multiple systems; advanced skills in Microsoft Office products (including Outlook, Word, and Excel) Global player in a global PV organization.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation And Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - Virtual
U.S. Base Salary Range
$137,000.00 - $215,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Apply Now
Back to nav
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Industries Venture Capital and Private Equity Principals Referrals increase your chances of interviewing at Takeda Digital Ventures by 2x Sign in to set job alerts for “Senior Clinical Scientist” roles.
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Join to apply for the
Senior Principal Pharmacovigilance Scientist
role at
Takeda Digital Ventures Senior Principal Pharmacovigilance Scientist
3 weeks ago Be among the first 25 applicants Join to apply for the
Senior Principal Pharmacovigilance Scientist
role at
Takeda Digital Ventures Job Level: Senior Travel: Minimal (if any)
Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.
In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.
Back to nav
Job ID
R0157855
Date posted
07/11/2025
Location
Remote
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 with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a
Senior
Principal Pharmacovigilance Scientist
where you will provide pharmacovigilance functional area expertise to project teams for assigned developmental and marketed products and be responsible for operational pharmacovigilance activities for assigned developmental and marketed products. You will represent pharmacovigilance, both regionally and globally as an authoritative and knowledgeable member of Global Clinical Development Teams (GCDTs) and similar, determined by the position's seniority/experience. You will also be involved in signal detection/safety monitoring activities for pharmacovigilance operations with a lead responsibility. As part of the GPSE Global Medical Safety team, you will report to the Senior Medical Director, GI and work with the broader safety cross-functional groups.
How You Will Contribute
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 timelyattainment of compliant and patient-focused safety data. Represent the 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-depthknowledge and understanding of designated products/studies. Expect close interaction and involvement with senior PV physicians. Provide support and oversight of pharmacovigilance operational activities for designated compounds. Conduct project activities for designated developmental products. Lead set up of safety procedures for complex developmental programs. Contribute to the development of safety exchange agreements for co-development projects. Review and provide functional area expertise for the development of protocols, IBs, SAPs, CSRs, and other relevant project/study documents. Close knowledge of protocols to effectively respond to safety issues. 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 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.
Minimum Requirements/Qualifications
Bachelor's degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, Ph.D., and PharmD). 6+ years of related experience required. Prior experience must include: Conducting safety signal detection, assessment, and management from various sources including medical scientific literature and global safety database (2 years); performing the medical assessment of the individual case and aggregate safety reports for product safety profile and addressing safety -elated regulatory authority requests (2 years); apply clinical trial methodology, various regulatory submissions, pharmacovigilance regulations, and safety profile to perform risk/benefit analysis (risk management plan) (2 years); utilize proficient communication skills with the ability to review, analyze, interpret and present complex safety data to a high standard during internal and global cross-functional collaborations for patient safety (2 years). Excellent databases skills and detailed understanding of MedDRA codes including the 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, analyze, interpret, and present complex data to a high standard. Advanced computer skills with the ability to work within multiple systems; advanced skills in Microsoft Office products (including Outlook, Word, and Excel) Global player in a global PV organization.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation And Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - Virtual
U.S. Base Salary Range
$137,000.00 - $215,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Apply Now
Back to nav
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Industries Venture Capital and Private Equity Principals Referrals increase your chances of interviewing at Takeda Digital Ventures by 2x Sign in to set job alerts for “Senior Clinical Scientist” roles.
Waltham, MA $135,000.00-$189,000.00 2 weeks ago Clinical Scientist, Clinical Development
Waltham, MA $140,000.00-$155,000.00 2 months ago Associate Director, Drug Safety and Pharmacovigilance (PV) Scientist
Waltham, MA $175,000.00-$200,000.00 4 days ago Boston, MA $176,000.00-$200,000.00 6 days ago Senior Principal Pharmacovigilance Scientist
Boston, MA $137,000.00-$215,270.00 3 days ago Senior Principal Pharmacovigilance Scientist
Boston, MA $137,000.00-$215,270.00 3 days ago Associate Director, Analytical Development & QC
Waltham, MA $179,200.00-$224,000.00 21 hours ago Senior Manager/Associate Director - CMC Analytical Development (Fully Remote), Pulmovant
Senior Principal Pharmacovigilance Scientist
Massachusetts, United States $137,000.00-$215,270.00 3 weeks ago Waltham, MA $215,000.00-$246,000.00 2 months ago Boston, MA $176,000.00-$200,000.00 3 days ago Director, Field Health Economics & Outcomes Research (HEOR)
Medical Science Liaison - Southeast U.S.
Boston, MA $185,000.00-$225,000.00 2 weeks ago Experienced Clinical Research Associate - Hematology/Oncology
Boston, MA $90,000.00-$140,000.00 2 weeks ago Medical Science Liaison (MSL, TED/Graves' Disease)- New England
Senior Medical Science Liaison, Solid Tumor, New Products - Northeast
Scientist II, Real World Data Science - Translational Research
Sr. Scientist/Associate Director, Pharmacometrics
Cambridge, MA $149,069.00-$223,604.00 1 month ago Senior Medical Science Liaison – Dermatology - New England
Massachusetts, United States $150,500.00-$236,500.00 4 weeks ago Senior Medical Science Liaison – Dermatology - New England
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr