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
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