Senior Principal or Principal Pharmacovigilance Scientist

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: February 25, 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. Senior Principal or Principal Pharmacovigilance Scientist 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. Senior Principal or Principal Pharmacovigilance Scientist Job ID R0030108 Date posted 02/04/2021 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 Senior Principal or a Principal Pharmacovigilance Scientist in our Cambridge, MA office. OBJECTIVES:

• Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products.
• Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products.
• Represent pharmacovigilance, both regionally and globally as an authoritative and knowledgeable member of Global Clinical Development Teams (GCDTs) and similar, commensurate with position's seniority/experience.
• Closely involved in signal detection/safety monitoring activities for pharmacovigilance operations with a lead responsibility.
• Provide functional & therapeutic area expertise, supporting less experienced colleagues and the safety effort more generally.--
• Flexible outside of primary therapeutic area as directed by business and departmental need. ACCOUNTABILITIES:
  • 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 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 development of safety exchange agreements for co-development projects
    • Review and provide functional area expertise for 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. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
      • Bachelor's degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD).
      • 8+ years of related experience.
      • Excellent databases and coding skills including 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.
      • Global player in a global PV organization.
      • Excellent communication and presentational skills.
      • Good level of computer literacy.
      • Excellent organization skills and ability to prioritize. 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 , Senior Principal or Principal Pharmacovigilance Scientist, Other , Cambridge, Massachusetts