Posted to MedZilla on 3/26/2017


Takeda Pharmaceuticals

US-MA, Associate Medical Director Pharmacovigilance - GI 1700247-MZ


 
 

OBJECTIVES:
  • Supporting Global Safety Lead for designated products or, as appropriate, undertaking a GSI role
  • Responsible for oversight of signal detection and risk management activities for designated global products together with usual safety mandated remit
  • Flexibility outside of primary therapeutic area as directed by business and departmental need.

ACCOUNTABILITIES:

  • Supporting GSL role for compound(s) both in development and marketed in close association with the TAL
  • As appropriate, being the compound(s) GSL
  • Intimate awareness of safety for his/her compound responsibilities, including any emerging safety concerns and risk/benefit profile
  • As appropriate, mentoring/involvement 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
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Medical Degree required or internationally recognized equivalent.
  • 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 license preferred
  • EU - registered to practice in the EU.
TRAVEL REQUIREMENTS:
  • Some travel to global Takeda sites may be required.



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Schedule

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