Executive Director, Global Safety

 

Location – Boston, Mass

In your role as Executive Director, you will report to Chief Medical Officer your responsibilities will include:

 

  • Managing and conducting ongoing safety surveillance on company products ensuring practices orderly and proactive pharmacovigilance for its products;

 

  • Coordinating the development  of guidelines and ensures the uniform and timely processing of adverse event reports and ensuring proactive analysis of safety information;

 

  • Interfacing with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements;

 

  • Overseeing the development and preparation of reports for company management as well as external regulatory agencies;

 

  • Overseeing the preparation of new drug application safety updates, investigational new oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety;

 

  • Assisting in defining the global development strategy for clinical research; assisting in the clinical management of new compounds in the assigned therapeutic area;

 

  • Establishing and reviewing protocols, investigator  brochures, study reports and other documents and  ensuring that study protocols are clinically appropriate, feasible and operational; and,

 

•             Recruiting, hiring, retaining, and developing Pharmacovigilance Safety staff