Associate Manager, PV Compliance – Excellence

This is a fully remote position, open to applicants in Canada.

📋 Description

• Manage the pharmacovigilance compliance framework for safety reporting within patient support, pharmacy, and infusion clinic operations, ensuring adherence to agreements, regulations, and internal protocols.

• Direct and sustain a risk-based quality control program for pharmacovigilance intake and reporting, which includes sampling, review criteria, performance benchmarks, and monitoring activities.

• Supervise quality assessments of adverse event and product complaint documentation to guarantee timeliness, completeness, accuracy, regulatory compliance, documentation quality, and adherence to privacy standards.

• Track compliance metrics, quality trends, deviations, and operational risks while preparing reports for quality and governance reviews.

• Lead inquiries into pharmacovigilance deviations, reconciliation discrepancies, procedural non-compliance, and documentation challenges using root-cause analysis techniques.

• Evaluate the ramifications of quality issues on patient safety, data integrity, regulatory obligations, and contractual commitments.

• Develop, assign, monitor, and assess Corrective and Preventive Actions (CAPAs) to ensure accountability, timely completion, effectiveness, and escalation of unresolved matters.

• Inform manufacturer partners of reportable deviations and compliance issues as per contractual obligations, while escalating significant risks to quality and pharmacovigilance leadership.

• Oversee the creation, review, and upkeep of pharmacovigilance training materials and ensure that personnel are qualified prior to engaging in safety reporting tasks.

• Provide training, coaching, and awareness sessions to operational, clinical, pharmacy, and cross-functional teams.

⛳️ Requirements

• A Bachelor’s degree in Health Sciences, Life Sciences, Nursing, Pharmacy, or a related discipline is required.

• A minimum of 5 years of experience in pharmacovigilance, adverse event reporting, safety case management, medical information, or a related healthcare sector is necessary.

• Previous experience in a Patient Support Program (PSP), specialty pharmacy, infusion clinic, or other regulated healthcare setting is preferred.

• Strong understanding of pharmacovigilance principles, adverse event reporting mandates, and safety case management procedures.

• Capability to perform root-cause analyses, identify trends, evaluate compliance risks, and implement effective corrective measures.

• Experience in developing, delivering, and sustaining training and awareness initiatives.

• Bilingual proficiency in French and English is required for this position to communicate effectively with internal and external stakeholders.

🏝️ Benefits

• Epic Work-Life Balance: Flexible remote work options because we value your time and well-being.

• Growth Opportunities: Committed to fostering a culture of growth, where every team member is encouraged to pursue new skills, expand their knowledge, and advance their careers.

• Vibrant Culture: Over 1,500 team members across Canada and year over year we manage to maintain an overall above industry engagement score by using a monthly pulse survey.

• Attractive Compensation: Competitive salary, incentive program, and comprehensive benefits package.