Senior Principal Pharmacovigilance Scientist

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: January 12, 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 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 2020. Senior Principal Pharmacovigilance Scientist Job ID R0024336 Date posted 10/26/2020 Location Boston, Massachusetts 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 Pharmacovigilance Scientist in our Cambridge, MA office. Primary responsibilities include but are not limited to:

• Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products. As appropriate and exceptionally, may be the lead safety support for a compound as the Global Safety Lead (GSL).
• 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 and particularly when the designated GSL.
• Closely involved in signal detection/safety monitoring activities for pharmacovigilance operations with a lead responsibility if the designated GSL.
• 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 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.
  • The attainment of advanced compound expertise might, for exceptional individuals, allow for Global Safety Lead (GSL) responsibilities where the individual has demonstrated both the requisite depth of knowledge and associated advanced communication skills.
  • 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. If the responsible GSL, will be seen as the company's lead responder and source of expertise for safety related issues for designated compound.
  • Expect close interaction and involvement with senior PV physicians and the safety Therapeutic Area Lead (TAL), particularly when the responsible GSL.
  • Provide support and oversight of pharmacovigilance operational activities for designated compounds, with lead responsibilities when acting as the GSL
  • Mentorship and guidance for less experienced colleagues within the department.
  • Lead set up of safety procedures for complex developmental programmes.
    • 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
    • Providing investigator and monitor training on safety procedures
    • Participate in Global Safety Teams, coordinating all aspects of signal detection/safety review activities.
    • Draft responses to regulatory/ethics safety questions
    • Assist with writing and maintenance of the Safety Monitoring Plan
    • Assist with set-up and running of DSMBs
    • 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, BEHAVIOURAL 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, analyse, interpret and present complex data to a high standard.
      • Global player in a global PV organisation.
      • Excellent communication and presentational skills.
      • Good level of computer literacy.
      • Excellent organisation skills and ability to prioritise. 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 Pharmacovigilance Scientist, Other , Cambridge, Massachusetts