Associate Manager, PV Compliance – Excellence

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BioScript Solutions

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2001

💊 Pharmaceuticals

🤝 B2B

Pharmaceuticals • B2B

BioScript Solutions is a Canadian specialty pharmacy and specialty-care services provider that helps patients with chronic and complex conditions access specialty drug therapies. The company operates infusion clinics and pharmacies, runs patient support programs, and offers wholesale pharmaceutical distribution and third-party logistics to manufacturers, payors and healthcare practitioners across Canada. BioScript focuses on patient-centred care, medication delivery and care coordination to improve health outcomes and simplify access to specialty treatments.

📋 Description

• Oversee the pharmacovigilance compliance framework for safety reporting across patient support, pharmacy, and infusion clinic operations, ensuring alignment with agreements, regulations, and internal procedures. • Lead and maintain a risk-based quality control program for pharmacovigilance intake and reporting, including sampling, review criteria, performance benchmarks, and monitoring. • Oversee quality reviews of adverse event and product complaint records to ensure timeliness, completeness, accuracy, regulatory compliance, documentation quality, and privacy adherence. • Monitor compliance metrics, quality trends, deviations, and operational risks, and prepare reports for quality and governance review. • Lead investigations into pharmacovigilance deviations, reconciliation discrepancies, procedural non-compliance, and documentation issues using root-cause analysis methodologies. • Assess the impact of quality issues on patient safety, data integrity, regulatory obligations, and contractual commitments. • Develop, assign, monitor, and evaluate CAPAs to ensure accountability, timely completion, effectiveness, and escalation of unresolved issues. • Notify manufacturer partners of reportable deviations and compliance concerns in accordance with contractual requirements and escalate significant risks to quality and pharmacovigilance leadership. • Oversee the development, review, and maintenance of pharmacovigilance training materials and ensure personnel are qualified before performing safety reporting activities. • Deliver training, coaching, and awareness sessions to operational, clinical, pharmacy, and cross-functional teams.

🎯 Requirements

• Bachelor’s degree in Health Sciences, Life Sciences, Nursing, Pharmacy, or a related field required. • Minimum 5 years of experience in pharmacovigilance, adverse event reporting, safety case management, medical information, or a related healthcare field. • Experience within a Patient Support Program (PSP), specialty pharmacy, infusion clinic, or other regulated healthcare environment preferred. • Strong knowledge of pharmacovigilance principles, adverse event reporting requirements, and safety case management processes. • Ability to conduct root-cause analyses, identify trends, assess compliance risks, and implement effective corrective actions. • Experience developing, delivering, and maintaining training and awareness programs. • Bilingualism (French and English) is required for this position to effectively communicate 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.