Posted to MedZilla on 9/18/2018

Takeda Pharmaceuticals

US-MA, Assoc Medical Director Pharmacovigilance R0002152-MZ


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Job Description

  • 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.
  • 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
  • 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.
  • Training and mentoring of Pharmacovigilance Physicians and Specialists
  • Perform activities required to serve as Global PV physician:

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