Hybrid Reg Affairs Ops / Drug Safety Specialist

Employment Permanent Date display: 24/12/2019 #Ref.:3347

Activity area : Pharmaceutical and medical

Post category : Scientific and technical positions

Province : Ontario

Region : GTA-West, Toronto

Recruiter : Anne Loiselle

Contact us : aloiselle@hubbletalent.ca

Job description :

Our client, a worldwide pharmaceutical company is presently looking for a RA/PV specialist. At this role you will be responsible to:

  • Receive, review and document the complaints received from complainant
  • Assess the nature of a complaint or adverse event to ensure alignment with this procedure and/or Health Canada Regulations pertaining to Pharmacovigilance
  • Follow up with complainant to gather outstanding information, if needed
  • Upload all ICSRs into safety database system  
  • Check the Safety Drug Inbox (at least once per business day) to ensure all complaints recorded are detected, logged and reported to Global within 24 hours.
  • Conduct a translation of the information received in French, if applicable. (if no French, manage translation with translator)
  • Receive and monitor the Annual Summary Report in the local database
  • Conduct Local Literature review and report identified cases to Global
  • Manage Issue-Related Reports  
  • Manage ODCS cases
  • Assist during the Agency inspection
  • Participate in Self inspection program
  • Initiate and manage CAPAs when applicable
  • Initiate and manage deviations , when applicable

 

Skills and qualifications :

Bachelor degree in Sc or related to Reg Affairs

  • Minimum of 2 years of experience in a similar role
  • Familiar with Health Canada regulations
  • Agility and creativity
  • Ability to manage time and priority
  • Muti-tasking

Bilingualism will be an asset ( not mandatory)