Patient Safety and Pharmacovigilance Specialist
New
W
WEP ClinicalPharmacovigilance
Remote, CanadaFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 3+ years’ experience in drug safety / pharmacovigilance in the CRO or pharmaceutical industry
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Bachelor’s degree in a medical, nursing, pharmaceutical, or life sciences discipline.
- 3+ years’ experience in drug safety or pharmacovigilance in the CRO or pharmaceutical industry.
- Experience in clinical trials and drug development, phases 1–4.
- Working knowledge of Argus Safety Database.
- Familiarity with FDA regulations and ICH guidance.
- Computer literacy and proficiency in Microsoft Office, particularly Word, Excel, and PowerPoint.
- Effective verbal and written communication skills.
- Strong organizational skills and attention to detail.
- Ability to work effectively in a fast-paced environment and manage changing priorities.
- An advanced degree such as BPharm, PharmD, RN, MD, MSc, or equivalent is strongly preferred.
Responsibilities
- Monitor the Pharmacovigilance System and develop monthly performance reports to support regulatory compliance and process effectiveness.
- Prepare and analyze PV metrics, including KPIs, quality incidents, CAPAs, audits, and inspection outcomes.
- Compile and trend compliance data, conduct root cause assessments and gap analyses, and evaluate corrective actions.
- Evaluate safety reports and study documents for completeness, accuracy, and clinical relevance.
- Support audit and inspection readiness and assist during internal audits and health authority inspections.
- Manage the safety mailbox, assess adverse event reports, and coordinate medical evaluations and escalations.
- Author Safety Monitoring Plans, process adverse events in Argus, and review and submit safety reports to regulatory agencies.
- Conduct literature reviews, reconcile adverse event reports with partners, resolve queries, and maintain adverse event logs.
- Provide training on adverse event reporting and train and oversee staff.
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