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Senior Principal Pharmacovigilance Scientist

at Takeda Pharmaceuticals in Montpelier, Vermont, United States

Job Description

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Job Description

About the role:

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 together with pharmacovigilance physicians. You will also represent the pharmacovigilance department internally and externally at a global level and to function as an authoritative and professional member of relevant teams. You will coordinate all aspects of signal detection and safety surveillance and review activities, in collaboration with or as GSL, for assigned product(s). As part of the Global Patience Safety and Evaluations and Medical Safety team, you will report to a Medical Director, PV.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Principal Pharmacovigilance Scientist working in the Medical Safety Team, you will provide pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products in conjunction with pharmacovigilance physicians. A typical day will include:

How will you contribute:

+ 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

+ Represent pharmacovigilance department in cross-functional teams or committees and external environments at a global and regional level as required.

+ In depthknowledge and understanding of designated products/studies.

+ The attainment of advanced compound expertise might, for exceptional individuals.

+ Facilitate ongoing safety surveillance for assigned products, assisting with or leading data collection and assessment for the GPSE Safety Team (GST) and Safety Management Team (SMT).

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

+ Assist with or lead authoring of 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 and provide input for appropriate sections of critical documents (e.g., protocols and amendments, ICFs, IBs, core data sheets, IMPDs, CSRs, INDs, NDAs, BLAs, and CTAs).

+ 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 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.

+ Assist with or lead the preparation and presentation of identified and potential patient safety risks and SMT recommendations on safety issues to cross-functional decision-making bodies such as the Takeda Safety Board. 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, manage the short timelines that can ensue.

+ Build and 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 outstanding 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 newly hired peers and incumbent PV Scientists.

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

Minimum Requirements/Qualifications:

+ Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent degree qualification.

+ Minimum 8 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, analyze, interpret and present complex data to a high standard, with keen attention to detail.

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

What Takeda can offer you:

+ Career and Professional/Development Growth

+ 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 company match of charitable contributions

+ Family Planning Support / Paid Bonding Leave

+ Flexible Work Paths

+ Tuition reimbursement

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.

Base Salary Range : $ 130,000 to $ 186,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

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

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Job Posting: JC226110693

Posted On: Oct 13, 2022

Updated On: Jan 15, 2023

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