Posted to MedZilla on 7/20/2018


Takeda Pharmaceuticals

US-MA, Associate Director Signal Management R0002712-MZ


 
 

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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 Signal Management in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the Global Patient Safety team, you will be empowered to Innovate and Collaborate. A typical day will include:

ACCOUNTABILITIES:

  • Ensures signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes (eg with Global Regulatory Affairs, Data Sciences).
  • Ensures that Takeda Signal Management processes and activities are compliant with EU regulations and EU regulatory authority and inspectors expectations.
  • Represents Pharmacovigilance and Takeda externally at a global level as an authoritative expert on signal detection processes.
  • Leads training for GPSE and other relevant functions on signal detection processes to ensure training and compliance with processes are maintained.
  • Leads interactions with other GPSE functions including EU QPPV and Global Medical Safety to ensure processes are regularly updated and are fit for purpose.
  • Leads interactions and oversight of signal management activities conducted by any vendor.
  • Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal GPSE stakeholders.
  • Leads interactions with other relevant functional areas both within and outside of GPSE to ensure standards are maintained.
  • Represents the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required.
  • Designs and delivers relevant training as appropriate.
  • Provides mentorship and guidance for junior/new pharmacovigilance scientists and others as appropriate.
  • Conduct project activities for designated processes.
  • Any other tasks assigned by manager to assist in related departmental activities.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Health care background or life science degree
  • Bachelors required; degree in life sciences preferred
  • Excellent document creation skills
  • In depth knowledge of clinical trial methodology, pharmacovigilance regulations, signal detection 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 presentation skills
  • Good level of computer literacy
  • Excellent organization skills and ability to prioritize

TRAVEL REQUIREMENTS:

  • Some domestic and international may be required on an infrequent basis

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • 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
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Please visit our website at takedajobs.com

 
 


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