Posted to MedZilla on 3/25/2017


Takeda Pharmaceuticals

US-MA, Director, Pharmacoepidemiology 1602893-MZ


 
 

OBJECTIVES:

  • The purpose of this position is to provide technical and strategic project support to meet product(s) strategic objectives. The following are key elements of position objectives:
  • Partner with Takeda teams by undertaking observational studies to support developmental and marketed products including:
    • Design and planning of observational studies of safety of Takeda products
    • Analysis and interpretation of epidemiologic data
    • Strategic input into regulatory documents, such as Risk Management Plans, Periodic Benefit-Risk Evaluation Report, and responses to enquiries of regulatory agencies
    • Issues resolution regarding clinical safety of developmental and marketed products, including evaluation of new hypotheses, appraisal of published epidemiological studies concerning Takeda products, defense of marketed products
  • Provide expertise and input in the identification and quantification of risks associated with exposure to developmental or marketed products, by applying epidemiological data and observational research techniques
  • Network with external researchers in the field in order to remain on top of best practices and enhance Takeda s visibility in the area of pharmacoepidemiology

ACCOUNTABILITIES:

  • Responsible for providing technical expertise and guidance on observational research and epidemiologic methodology
  • Provide epidemiologic support to project teams, including detailed knowledge on epidemiology of target diseases, published literature on topics of interest, and data sources suitable for epidemiologic studies
  • Develop, implement, and analyze observational studies to support developmental and marketed products, and disease areas of interest
  • Input into regulatory documents such as Risk Management Plans, Periodic Benefit-Risk Evaluation Reports, and responses to regulatory queries
  • Responsible for issues resolution regarding clinical safety of developmental and marketed products, including evaluation of new hypotheses, appraisal of published epidemiological studies concerning Takeda products, defense of marketed products

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Ph.D in Epidemiology is required
  • Master In Public Health or similar would be an advantage
  • Scientific credibility including publications in peer-reviewed epidemiologic journals
  • Knowledge of the epidemiologic methods involved in the quantification of potential safety signals, the determination of cause and effect relationships for potential safety signals and the application of epidemiologic methods
  • Excellent qualitative and quantitative epidemiological skills, including study design and analysis of health insurance claims and other automated healthcare databases.
  • Familiarity with software for management and analysis of epidemiologic data
  • Ability to work independently as well as in a team and to manage multiple projects to tight deadlines
  • Excellent communication skills, both written and oral
  • Ability to work in a global environment

PHYSICAL DEMANDS:

  • Routine demands of an office based environment.
TRAVEL REQUIREMENTS:
  • 10-20% Domestic and International


we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx


*LI-PG1-USA

No Phone Calls or Recruiters Please.


Schedule
Full-time

Please visit our website at takedajobs.com

 
 


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