Drug Safety Associate
4 weeks ago
We are seeking a highly skilled and detail-oriented Drug Safety Associate to join our team at Innomar Strategies. As a key member of our pharmacovigilance team, you will be responsible for receiving, documenting, and analyzing clinical information to ensure compliance with regulatory requirements.
Key Responsibilities- Receive and document clinical information in compliance with SOPs and regulatory guidelines
- Work with internal and external clients to request additional information or clarification as necessary
- Review source data documents and triage adverse event information and product quality complaints
- Enter data into program-specific databases and perform quality checks on adverse event reports
- Assist with source data verification checks and screening medical and scientific literature for safety information
- Prepare reconciliation reports and perform transcription, translation, and redaction activities
- Assist with non-conformance/CAPA process and perform other duties as required
- Minimum college-level education required; diploma or degree with a concentration in Life Sciences is an asset
- 1-3 years experience in medical information, clinical research, or drug safety or equivalent experience in pharmacy or pharmaceutical fields
- Knowledge of pharmacovigilance industry, including up-to-date knowledge of Health Canada, US FDA, EMEA, and ICH guidelines
- Adaptability to change and ability to learn new skills as required
- Experience in medical and/or pharmaceutical fields, medical terminology is an asset
- Bilingual, English/French is an asset
We provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This includes support for working families, training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and more.
Equal Employment OpportunityInnomar Strategies is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.
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