Pharmacovigilance Senior Medical Director

 

Junto HLS is working with Sr. Leadership on a Pharmacovigilance Senior Medical Director position for a top pharmaceutical company in Chicago, IL.

Select Accountabilities:

  • Support developmental programs.
  • 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.
  • Line management responsibilities for junior physicians and/or scientists
  • Global Safety Lead role for compound(s) both in development and marketed
  • 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

Location(s):

  • Greater Chicago, IL

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.