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Medical Director, Global Patie...

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Job Summary

Company
Takeda
Location
Cambridge, MA
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4314_R0001175

Medical Director, Global Patient Safety Evaluation

About the Job

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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 a Medical Director, Pharmacovigilance in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Medical Director working on the Pharmacovigilance team, you will be empowered to Innovate and Strategize. A typical day will include: 

POSITION OBJECTIVES:

  • Support developmental programs, including both early and late stage development as required.
  • Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate. 
  • Supporting Therapeutic Lead 
  • Line management responsibilities for junior physicians and/or scientists
  • Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs

POSITION ACCOUNTABILITIES:

  • Expectation of GSL role for compound(s) both in development  and marketed in close association with the TAL.
  • Company wide safety expert for his/her compound responsibilities
  • Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for ‘own’ compounds with input for other compounds as needed.
  • Serving in a leadership capacity for complex and strategically important  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 MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc
  • Training and mentoring of Pharmacovigilance Physicians and Specialists
  • Perform activities required to serve as Global PV physician:
    • Review and oversight of safety data, both non-clinical and clinical
    • Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
    • Interactions with external experts and regulatory agencies and partner/co-development companies
    • Review of safety data and participate in dose escalation decisions
    • Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
    • 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
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:  

  • Qualified physician (Licence, e.g. GMC registered, preferred)
  • 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
  • Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development

  • 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine

TRAVEL REQUIREMENTS:

  • Estimated 5-10 times per year including international travel

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.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
 

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