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Assoc Medical Director Pharmac...

Monster
 
 
 
 

Job Summary

Company
Takeda
Location
Boston, MA
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4314_R0002152

Assoc Medical Director Pharmacovigilance

About the Job

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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:

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
 

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