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Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Responsibility:
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 as necessary
Review of source data documents (includes visit report/PIR review) and triaging adverse event information and product quality complaints as per client needs
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 (weekly, monthly etc.) Reports
Transcription, translations and redaction activities
Preparation and conducting solicited follow-up letters and data clarifications
Assist and participate in the non-conformance/CAPA process
The Drug Safety Associate will also be assigned other duties and tasks as required from time to time
May be required to be on standby/on call as part of this role
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 and related experience in pharmacy or pharmaceutical fields
Knowledge of Pharmacovigilance industry including up to date knowledge of
pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH
Adaptability to change and to learn new skills as required
Experience in the medical and/or pharmaceutical field(s), medical terminology is an asset
Bilingual, English/French is an asset
Able to work any 8-hour shift between 8:00 AM-8 PM, if necessary
Strong analytical skills
Ability to communicate effectively both orally and in writing
Effective interpersonal skills
Effective organizational skills
ability to multitask
Superior, proven attention to detail
Ability to consistently meet deadlines
Excellent problem-solving skills
ability to communicate and/or resolve issues effectively and efficiently
Computer skills (including knowledge of Microsoft Word, Excel, PowerPoint and other Office Programs)
Good internet required for remote work
Nice to have:
A diploma or degree with a concentration in Life Sciences
Experience in the medical and/or pharmaceutical field(s), medical terminology
Bilingual, English/French
What we offer:
medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families
backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions
paid parental leave
paid caregiver leave
variety of training programs
professional development resources
opportunities to participate in mentorship programs