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About the role
Key responsibilities & impact- Receive, scan, and document pertinent clinical information in compliance with SOPs, protocols, and applicable legislation
- Work with internal and external clients to request additional information or clarification
- Review source data documents, including visit report/PIR reviews
- Triage adverse event information and product quality complaints according to client needs
- Enter and submit adverse event information and product quality complaints into program-specific databases
- Sort and file incoming documents
- Perform quality checks on adverse event reports according to work instructions
- Assist with and/or perform source data verification checks
- Screen medical and scientific literature for safety information
- Prepare reconciliation reports, transcription translations, and redaction activities
- Prepare and conduct solicited follow-up letters and data clarifications
- Assist and participate in the non-conformance/CAPA process
- Perform other assigned duties and tasks as required
Requirements
What you’ll need- Minimum college level education required
- Diploma or degree with a concentration in Life Sciences is a strong asset
- 1–3 years of experience in Medical Information, Clinical Research, Drug Safety, or equivalent related experience in pharmacy or pharmaceutical fields
- Knowledge of the pharmacovigilance industry
- Up-to-date knowledge of pharmacovigilance guidelines from Health Canada, US FDA, EMEA, and ICH
- Adaptability to change and willingness to learn new skills as required
- Experience in medical and/or pharmaceutical fields; medical terminology is an asset
- Bilingual English/French is an asset
- Strong analytical skills
- Effective oral and written communication skills
- Effective interpersonal skills
- Effective organizational skills and ability to multitask
- Superior, proven attention to detail
- Ability to consistently meet deadlines
- Excellent problem-solving skills
- Computer skills, including Microsoft Word, Excel, PowerPoint, and other Office programs
- Good internet required for remote work
Benefits
Comp & perks- Medical, dental, and vision care
- Backup dependent care
- Adoption assistance
- Infertility coverage
- Family building support
- Behavioral health solutions
- Paid parental leave
- Paid caregiver leave
- Training programs
- Professional development resources
- Mentorship programs
- Employee resource groups
- Volunteer activities
- Remote work arrangement
