About Dermavant:

Dermavant Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory skin diseases and medical dermatologic conditions.  We are passionate and dedicated to realizing the full potential of biomedical research and to developing and commercializing novel first-in-class or best-in-class therapies that improve patients’ lives. The patient is at the heart of everything we do.

Position:

The Pharmacovigilance Specialist will assist the Head of Pharmacovigilance to achieve regulatory requirements and company policies regarding pharmacovigilance activities, all in furtherance of  Dermavant’s commitment  to  patient safety. 

     

Main Responsibilities:

  • Ensuring all postmarketing adverse event reports from any source (including call center, e-mail, facsimile, mail, literature other manufacturers and partners, FDA or other foreign regulatory agencies) are captured and entered accurately into the Dermavant Global Safety Database
  • Keeping performance metrics on adverse event processing and follow-up times with particular emphasis on initial 15-day reports including any follow-up reports
  • Assisting in review of safety data for signal detection from all sources including clinical trial and postmarketing data for aggregate reports and safety signal detection, including preparation of tables, listings, and graphs in conjunction with the Head of Pharmacovigilance
  • Liaising with regulatory IT to maintain a real-time source for all applicable Dermavant and CRO SOPs, workflows, safety management plans, and medical monitoring plans are placed in a central location, to ensure all key documents and procedures are available for regulatory inspections
  • Initial development, updating, and revisions of internal Dermavant SOPs governing pre- and postmarketing drug safety
  • Maintaining qualifications and training files for pharmacovigilance staff and developing/documenting regular pharmacovigilance training and testing materials for all Dermavant employees and contractors
  • Reviewing weekly literature searches for safety signals and referring appropriate publications to the Head of Pharmacovigilance
  • Maintaining and updating a database of current regulations and guidances governing pre- and postmarketing drug safety
  • Providing and compiling reports on competitive safety data from the literature, presentations, and abstracts
  • Being familiar with MedDRA coding and documenting the regular updating of dictionary to ensure consistency in adverse event coding over time
  • Serving as the secretary for the Drug Safety Assessment Committee, scheduling meetings, assembling appropriate materials for discussion, keeping minutes and ensuring proper documentation in the TMF

     

Qualifications:

  • A university degree in health sciences, pharmacy, nursing, or a related discipline
  • Two to 5 years of pharmacovigilance experience, clinical research, or regulatory affairs
  • Knowledge and understanding of US and EU pharmacovigilance
  • Meticulous and attention to detail
  • Computer literacy and familiarity with relevant software and systems
  • Planning skills and organized work habits
  • Ability to effectively collaborate in a dynamic, fast-paced environment.

 

 

What we look for in our people:

  • Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development.
  • Desire to work in a quickly changing and fast-paced growing business.
  • Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done.
  • Ability to overcome ambiguity and challenge the status quo
  • Manage multiple programs with competing and aggressive time lines, prioritize activities, and work independently.
  • Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders
This position has been filled. Would you like to see our other open positions?