Lead Pharmacovigilance (PV) Scientist, Global Medical Safety at Takeda Development Center Americas, Inc. in Boston, Massachusetts

Job Description:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Lead Pharmacovigilance (PV) Scientist, Global Medical Safety, in our Cambridge, Massachusetts office or this role can be performed fully remote.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Lead Pharmacovigilance (PV) Scientist, Global Medical Safety , working on the Global Patient Safety Evaluation team, you will be empowered to provide core pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products in conjunction with the Global Safety Lead (GSL).  A typical day will include:

POSITION OBJECTIVES:

• Coordinates all aspects of signal detection and safety review activities.


• Supports GSL in overseeing the medical safety profile for assigned products.


• Coordinates and plays a critical role in the GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products.


• Provides functional and therapeutic area expertise in helping to manage the cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.

POSITION ACCOUNTABILITIES:

• Coordinate signal identification, evaluation and management activities for assigned products.


• Assist with authoring safety evaluations, defining scope and methodology and providing background information for aggregate safety reports, conducting preliminary safety analyses, and preparing ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses.


• Partner with cross-functional colleagues of the SMT and contribute to safety-related deliverables associated with new drug applications, benefit-risk assessments and activities related to risk minimization including RMPs.


• Liaise with colleagues in relevant functional areas within and outside of GPSE to gather input for appropriate sections of critical documents (e.g., protocols and amendments, ICFs, IBs, core data sheets, IMPDs, CSRs, INDs, NDAs, BLAs, and CTAs).


• Maintain in-depth knowledge and understanding of designated products/studies, and close knowledge of protocols to effectively respond to safety issues.


• Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents.


• Demonstrate knowledge of local and global health authority requirements.


• Support GPSE in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations.


• Train and mentor new PV Scientists.


• Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and foster a community of continual learning.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent qualification; advanced degree in scientific or medical field preferred.


• 2 years of relevant biotech/pharmaceutical experience.


• Excellent working understanding of safety database configuration and adverse event coding to direct advanced searches.


• In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis and benefit-risk assessment, and understanding of drug development.


• Good critical/analytical thinking and project management skills.


• Ability to review, analyse, interpret and present complex data to a high standard, with keen attention to detail.


• Competency in oral and written communications and presentations.


• Good level of computer literacy with commonly used software (e.g., Microsoft Excel, PowerPoint, Word).


• Team player that performs effectively in a fast-paced, cross-functional environment.


• Excellent organisation skills and ability to prioritise independently (with minimal supervision).


• Ability to coordinate, moderate, and clearly document conclusions of cross-functional scientific meetings.

This job posting excludes CO applicants

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

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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.

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