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Job Description

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Medical Director Pharmacovigilance

Job Location: Deerfield, IL

OBJECTIVE:

The Medical Director serves as the Global Safety Lead physician for complex, strategically important developmental programs especially those that are Phase III and IV programs. Responsible for the oversight of signal detection and risk management activities for designated global products. Ensures patient safety is adequately addressed in TGRD sponsored studies.


ACCOUNTABILITIES:


  • Serving in a leadership capacity on the GDT and RDT for complex and strategically important developmental programs including those that are Phase III and IV programs.
  • Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to Type II variations and sNDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs.
  • Training and mentoring of Pharmacovigilance Physicians and Specialists.
  • Perform activities required to serve as GlobalSafety Lead:

    • Act as PV GDT member and lead the Global Safety Team
    • Review and oversight of all safety data, including non-clinical and clinical, for the product
    • Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities for the product globally. This includes the authorship of the DCSI and Expectedness List for a compound.
    • Interactions with external experts and regulatory agencies
    • Review of safety data and participate in dose selection in first-in-man studies and dose escalation decisions
    • Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
    • Review or generation of monthly safety reports for signal detection
    • Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
    • Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
    • Oversight of selection of members, set up and conduct of DSM and Advisory Board activities
    • Conduct aggregate analysis of emerging safety data, present to senior management within TGRD and TPC and lead strategy in response to an emerging significant safety signal

  • Perform activities required to serve as regional PV physician:

    • Review of all local cases for the designated products
    • Assist with activities related to local regulatory agency interactions if required
    • Working knowledge and familiarity with clinical protocols, SAPs, clinical study reports and periodic reports for the product
    • Member of safety working group and participate in compilation and review of data to be used by the group

  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities.
Qualifications
EDUCATION, EXPERIENCE AND SKILLS:


  • Medical Degree required or internationally recognized equivalent.
  • Minimum of 4 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 2 years in global pharmacovigilance.
  • 1 year clinical experience with patients following post-graduate training with significant knowledge of general medicine.
  • Knowledge of principles of epidemiology and statistics.
  • Critical thinking and analytical skills and ability to make high level decisions.
  • Excellent oral and written communication skills including ability to present to large internal/external groups.
  • Good level of computer literacy with Microsoft applications.


LICENSES/CERTIFICATIONS:


  • US - Active US license preferred.
  • EU - registered to practice in the EU.

PHYSICAL DEMANDS:


  • Routine demands of an office-based work environment.

TRAVEL REQUIREMENTS:


  • Estimated 5-10 times per year including possible international travel.

We are driven to improve people's lives.




We are an equal opportunity employer.

No Phone Calls or Recruiters Please.


Schedule
Regular Full-time

Job ID: 1100673
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About Research and Development

Takeda is a research-based pharmaceutical company dedicated to delivering innovative medicines to patients. Our current focus is on the research and development of new treatments for metabolic diseases, cardiovascular disease, central nervous system disorders, chronic kidney disease, gastroenterology, oncology, and other diseases. In the United States, Takeda has drug discovery sites in California (Takeda San Diego and Takeda San Francisco), as well as a development center in Illinois (Takeda Global Research & Development). We have excellent career opportunities including Medical Directors, Clinical Scientists, Research Scientists, Medical Writers, Pharmaceutical Scientists, Statisticians, Project Managers, Quality Assurance jobs and more. Read on and discover your place at Takeda.

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Location Info

1 Takeda Parkway
Deerfield, IL 60015
United States of America
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