Takeda

Global Pharmacovigilance

Role:  Medical Director Global Pharmacovigilance, CNS, Oncology or GI

Location:  Cambridge, MA

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

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, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Qualified physician (License, 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

TRAVEL REQUIREMENTS:

5-10 times per year including international travel.