About the role

  • Drug Safety Associate responsible for clinical information management and client liaison role at Cencora in a supportive Pharma environment. Involves data entry, document management, and compliance tasks.

Responsibilities

  • Receive, scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
  • Work directly with internal and external clients to request additional information or clarification
  • Review of source data documents and triaging adverse event information and product quality complaints
  • Data entry and submission of adverse event information and product quality complaints into program specific databases
  • Sorting and filing of incoming documents
  • Perform quality check on adverse event reports as directed by the work instructions
  • Assist with and/or perform source data verification checks
  • Screening medical and scientific literature for safety information
  • Preparation of Reconciliation Reports
  • Assist and participate in the non-conformance/CAPA process

Requirements

  • Minimum college level education required
  • A diploma or degree with a concentration in Life Sciences is a strong asset
  • 1-3 years experience in Medical Information, Clinical Research or Drug Safety or equivalent
  • Knowledge of Pharmacovigilance industry
  • Up to date knowledge of pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH
  • Bilingual, English/French is an asset
  • Able to work any 8-hour shift between 8:00 AM-8 PM, if necessary

Benefits

  • Health insurance
  • Dental care
  • Vision care
  • Paid parental leave
  • Paid caregiver leave
  • Backup dependent care
  • Adoption assistance
  • Infertility coverage
  • Family building support
  • Professional development resources
  • Training programs
  • Mentorship programs
  • Employee resource groups
  • Volunteer activities

Job title

Job type

Contract

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Associate's Degree

Location requirements

RemoteCanada

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