Patient Safety and Pharmacovigilance Specialist

Accountabilities: Monitor the pharmacovigilance system and prepare monthly performance reports to assess regulatory compliance and process effectiveness. Prepare, analyze, and report pharmacovigilance metrics, including KPIs, quality incidents, CAPAs, audit findings, and inspection outcomes. Compile and trend compliance data, perform root cause assessments and gap analyses, and evaluate the effectiveness of corrective and preventive actions. Review safety reports and clinical study documentation to ensure completeness, accuracy, and clinical relevance. Support audit and inspection readiness, including participation in internal audits and health authority inspections. Provide training on adverse event reporting and participate in internal and external meetings as required. Manage the safety mailbox, assess incoming adverse event reports, and coordinate medical evaluations and escalations. Collaborate with cross-functional teams to strengthen pharmacovigilance processes and compliance activities across the organization. Develop Safety Monitoring Plans and process adverse events in the Argus Safety database in accordance with regulatory and client requirements. Review and submit safety reports to regulatory agencies, respond to queries, and maintain accurate adverse event logs. Conduct literature reviews to identify potential adverse events, reconcile safety reports with external partners, and manage product quality complaints. Act as a pharmacovigilance subject matter expert, support business development activities, train and oversee team members, and contribute to resource onboarding. Requirements Bachelor's degree in a medical, nursing, pharmaceutical, or life sciences discipline is required. An advanced qualification, such as BPharm, PharmD, RN, MD, MSc, or equivalent, is strongly preferred. At least 3 years of experience in drug safety or pharmacovigilance, preferably within a Contract Research Organization (CRO) or pharmaceutical company. Experience supporting clinical trials and drug development across Phases I–IV. Working knowledge of the Argus Safety database. Familiarity with FDA regulations and International Council for Harmonisation (ICH) guidelines. Strong written and verbal communication skills, with the ability to work effectively with international and cross-functional teams. Proficiency in Microsoft Office, particularly Word, Excel, and PowerPoint. Strong analytical, organizational, and problem-solving skills, with excellent attention to detail. Ability to work effectively in a fast-paced environment, adapt to changing priorities, and maintain a consistent focus on quality and regulatory compliance. A conscientious, adaptable, and quality-focused approach, supported by sound judgment and professional collaboration. Benefits Fully remote work: Opportunity to work remotely from Canada. Full-time employment: A dedicated role within a global clinical research and pharmacovigilance environment. Professional development: Opportunities to expand pharmacovigilance expertise, contribute to training, and take on subject matter expert responsibilities. Global exposure: Collaboration with international clinical trial sites, sponsors, and cross-functional teams. Wellness and team engagement: Employee initiatives designed to support well-being, professional growth, and team relationships. Meaningful contribution: Opportunity to support patient safety and help advance access to innovative treatments. Specific salary, healthcare coverage, paid leave, and additional compensation details are not specified in the job description.