Pharmacovigilance Associate managing adverse-event reporting and compliance for BioScript Solutions’ Canadian specialty-care programs. Supporting patient-focused pharmaceutical services remotely across Canada.
Responsibilities
Manage collection, processing, and reporting of adverse events and reconciliation reports
Recognize, triage, and report adverse events according to program or manufacturer requirements
Maintain high compliance standards for reporting timelines and report quality
Respond to stakeholder inquiries
Conduct Pharmacovigilance compliance activities
Assist with investigations into late adverse-event reports
Perform work on rotating shifts of 8:00 a.m.–4:00 p.m. EST, 9:00 a.m.–5:00 p.m. EST, and 10:00 a.m.–6:00 p.m. EST
Work occasional weekends
Perform other tasks as required
Requirements
BSc and/or BA related to Health Science
1–3 years of experience in Pharmacovigilance, Medical Information, Adverse Event Reporting, Safety Case Processing, Regulatory, or QA
Good understanding of safety regulations
Experience in medical and/or pharmaceutical fields, including exposure to medical terminology and/or scientific writing is an asset
Exceptional organizational skills and strong attention to detail
Proven analytical and problem-solving skills
CAPA investigation experience preferred
Change Control Management experience is an asset
Proficient in conducting Program Compliance
Above-average verbal and written communication skills
Demonstrated prioritization skills and ability to multitask to meet tight deadlines
Bilingual English/French is required
Comfortable working with computers and technology, specifically Microsoft Office
Benefits
Flexible remote work options
Growth opportunities and career advancement support
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