Senior Principal Pharmacovigilance Scientist, Gastrointestinal and Inflammation

Gated Talent; Boston (MA); Remote; USD 137,000 - 216,000; Full time

Job summary

Join a leading organization as a Senior Principal Pharmacovigilance Scientist where you will provide expertise in pharmacovigilance, ensuring compliant and patient-focused safety data across projects. You'll be part of a dynamic team committed to delivering life-changing therapies by leveraging your advanced skills in analysis and decision-making. This is an excellent opportunity for professionals looking to grow their careers in R&D.

Benefits

Development Opportunities

Comprehensive Healthcare

401(k) with company match

Generous vacation time

Flexible Work Paths

Qualifications

• 6+ years of related experience required.
• Knowledge of MedDRA codes and advanced database skills.
• In-depth knowledge of clinical trial methodology and pharmacovigilance regulations.

Responsibilities

• Conduct safety signal detection and management of safety data.
• Lead safety procedures for complex developmental programs.
• Participate in Global Safety Teams for signal detection/safety review.

Skills

Critical thinking

Communication skills

Data analysis

Team collaboration

Education

Bachelor’s degree required

Advanced degree or pharmacovigilance qualification preferred (MD, Ph.D., PharmD)

Tools

Microsoft Office

Job description

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.

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 in the Inflammation Team 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 timely attainment 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-depth knowledge 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.

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.

What Takeda can offer you:

Development Opportunities / Career Growth and Expansion

Comprehensive Healthcare: Medical, Dental, and Vision

Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

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 and a company match of charitable contributions

Family Planning Support and Family Leave

Flexible Work Paths

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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

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.

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