Associate Director, Pharmacovigilance (PV) Scientist

Company: Takeda Pharmaceuticals International GmbH
Location: Boston
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. Associate Director, Pharmacovigilance (PV) 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. Associate Director, Pharmacovigilance (PV) Scientist Job ID R0027296 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 an Associate Director, Pharmacovigilance (PV) Scientist in our Cambridge, Massachusetts office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Pharmacovigilance (PV) Scientist working on the Global Medical Safety team, you will p rovide strategic leadership and safety expertise, including support for regulatory submissions and responses, aggregate reports, white papers, etc. A typical day will include:-- OBJECTIVE:

• Expert from safety science perspective in primary therapeutic area
• Potential Global Safety Lead for one compound
• Flexible outside of primary therapeutic area(s) as directed by business and departmental need ACCOUNTABILITIES:--
  • Serve as the Global Safety Lead
  • Responsible for reviewing, analyzing, and interpreting information from ongoing clinical and non-clinical studies alongside the assessment of ensuing scientific and medical implications of making recommendations based on new safety information for both developmental compounds and marketed drugs to ensure the primacy of patient safety
  • PV science expert for designated compound(s) within primary therapeutic as appropriate oversees safety and process activities within these therapeutic areas.
  • Integral to GST and GCDT and assisting with writing/reviewing of aggregate reports including the RMP.
  • Direct, mentor, and develop PV Science colleagues commensurate with his/her experience.
  • Ability to functions as senior contact for safety related matters to cross functional groups and external bodies.
  • Maintains compound and more general safety expertise
  • Provides strategic and technical expertise and leadership. Sets medical, scientific and process standards for all products within these therapeutic areas.
  • Contributes to clinical program and protocol design, safety risk management, signal detection.--
  • Oversees PV reports and submissions in designated therapeutic area(s), e.g., aggregate reports and regulatory submissions.
  • In collaboration with the PV TA Lead, leads evaluation and management of emergent safety issues.
  • Ensures adequate internal support and external resourcing (CRO & BPO) to deliver all safety reports.
  • Ensures adequate distribution of assignments and prioritization of tasks within the PV specialist's staff.
  • Interfaces with functional areas within and outside PV. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
    • Bachelor's degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD).
    • Minimum 8 years experience in Pharmacovigilance with significant experience in preparing regulatory documents.--
    • Comprehensive understanding of PV process in aggregate submissions and the new regulations that have been established.
    • Demonstrated experience in people management and well-developed skills in team building, motivating and developing people.
    • Expert knowledge of clinical trial and pharmacovigilance methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements
    • Excellent organization skills and ability to prioritize individual and team work loads.
    • Excellent written and oral communication skills including ability to present to large internal/external groups
    • Capability to synthesize and analyze data from multiple sources.
    • Expertise in pre and post marketing SD.
    • Demonstrated leadership skills with proven ability to motivate and work in multidisciplinary teams. 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, Boston , Associate Director, Pharmacovigilance (PV) Scientist, Executive , Boston, Massachusetts