New · posted Nov 7
Takeda · Pharmaceuticals
Senior Principal Pharmacovigilance Scientist
- Boston, MA
- On-site
- Full-time
- Senior & Principal
The role
The Senior Principal Pharmacovigilance Scientist ensures regulatory compliance and safety of Takeda's products by managing large projects, developing innovative solutions, and leading teams. This role contributes to the development and execution of pharmacovigilance strategies, ensuring patient safety and regulatory adherence.
How you will contribute:
- Manage large pharmacovigilance projects or processes with limited oversight
- Develop and implement risk management strategies for complex situations
- Lead the preparation and review of detailed safety reports
- Conduct signal detection and safety assessments independently
- Engage with stakeholders and regulatory authorities, providing authoritative advice
- Lead and mentor junior staff, fostering a collaborative environment
- Deliver training on pharmacovigilance practices to enhance team capabilities
What you need
- Applies comprehensive risk management strategies in complex situations, capable of advising others
- Recognized as an expert in pharmacovigilance, able to develop strategic safety initiatives and coach others
- Ensures regulatory compliance with a deep understanding of safety regulations and guidelines
- Proficient in safety reporting and able to lead the preparation of detailed reports
- Conducts signal detection and safety assessments independently, providing critical analysis
- Experienced in clinical development, contributing to the strategic planning and execution of clinical trials
- Engages effectively with stakeholders and regulatory authorities, providing authoritative advice
- Leads teams effectively, fostering a collaborative environment and mentoring junior staff
- Delivers training on pharmacovigilance practices, enhancing team capabilities
- Communicates complex safety data clearly and effectively to various audiences
- Analyzes safety data meticulously to make informed decisions
- Demonstrates strong decision-making skills in high-stake environments
As an expert professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues, requiring in-depth analysis and judgment. You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards. Operating with considerable autonomy, you serve as a consultant to management and an external spokesperson on major matters, often working independently and leading function teams or projects. Additionally, you play a role in training and mentoring junior staff.
Pay
$137,000 – $215,270 a year
Employer providedU.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.
For information about our benefits, please click here.
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.
Where you'll work
Boston, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Boston, MAWorking conditions
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
Boston, MA
Job Exempt
YesIt 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.
Equal opportunity, accessibility and legal noticesTakeda's statements, word for word
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’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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.
Job intelligence
The context around this role
Live data · November 7, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% above the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US13 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $137,000 | — | $215,270 |
| All US (middle half) | $149,000 | $164,000 | $201,500 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 7, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 164 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- GMP and compliance2
- Documentation and SOPs2
- Quality systems and risk2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Safety & Pharmacovigilance work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA good pharmacovigilance practices(official source, opens in a new tab)Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
- FDAFDA FAERS(official source, opens in a new tab)The FDA Adverse Event Reporting System for drugs and biologics
- EMAEU Good Pharmacovigilance Practices (GVP)(official source, opens in a new tab)EMA's modules for pharmacovigilance systems, signals and periodic reports
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Takeda on Regulatory Jobs
- 66
- Open roles
- 66
- Distinct roles
- 16
- Locations
By discipline
- Regulatory26 39%
- Clinical22 33%
- Quality18 27%
By level
- Director39 58%
- Senior & Principal12 18%
- Manager9 13%
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Senior Principal Pharmacovigilance Scientist at Takeda
Open until filled. $137K–$215K a year, employer provided.