Principal or Sr Principal Pharmacovigilance (PV) Scientist, Global Medical Safety

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: February 24, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you. *Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info. Principal or Sr Principal Pharmacovigilance (PV) Scientist, Global Medical Safety Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units. We are a passionate team doing important work that impacts patients' lives. If you are driven to create better health and a brighter future, join us! Success What makes a successful member of our team? Check out the traits we're looking for and see if you have the right mix. Life at Takeda A Global Top Employer Recognized for our culture and way of working, we're one of only select companies to receive Top Global Employer -- status for 2021. Principal or Sr Principal Pharmacovigilance (PV) Scientist, Global Medical Safety Job ID R0031008 Date posted 02/16/2021 Location Boston, Massachusetts 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 Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Principal or Senior Principal Pharmacovigilance (PV) Scientist on our Global Medical Safety Team. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Principal or Senior Principal Pharmacovigilance (PV) Scientist working on the Global Medical Safety team, you will p rovide 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:-- OBJECTIVE:

• 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. ACCOUNTABILITIES:--
  • Facilitate ongoing safety surveillance for assigned products, assisting with data collection and assessment for GST and SMT.
  • Coordinate and perform 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 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).
  • Assist with the preparation of 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.
  • 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 strong 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 Lead PV Scientists.
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and foster a community of continual learning. EDUCATION, BEHAVIOURAL 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.
    • Minimum 5 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.
    • 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 organization skills and ability to prioritize independently (with minimal supervision).
    • Ability to coordinate, moderate, and clearly document conclusions of cross-functional scientific meetings. WHAT TAKEDA CAN OFFER YOU:
      • 401(k) with company match and Annual Retirement Contribution Plan
      • 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 Check out where you could be
        working if you apply. Job Seekers: Protect yourself against identity theft Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Principal or Sr Principal Pharmacovigilance (PV) Scientist, Global Medical Safety, Healthcare , Cambridge, Massachusetts