Associate Manager, PV Compliance – Excellence

BioScript Solutions

Oversee pharmacovigilance compliance and quality oversight for safety reporting at BioScript Solutions. Ensure alignment with agreements, regulations, and internal procedures for patient support and infusion clinic operations.

Posted 7/22/2026full-timeRemote • 🇨🇦 CanadaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance compliance, safety reporting, and quality control within healthcare environments, with a strong focus on training development and risk management. Proficient in conducting root-cause analyses and ensuring adherence to regulatory standards while effectively communicating in both French and English.

Highest-signal resume keywords

Pharmacovigilance ComplianceAdverse Event ReportingRoot-Cause AnalysisTraining DevelopmentBilingual Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmacovigilance PrinciplesSafety Case ManagementQuality Control ProgramCompliance Metrics MonitoringCorrective Action Plans (CAPAs)Risk AssessmentData Integrity AssessmentDocumentation Quality ReviewRegulatory CompliancePerformance Benchmarking

Soft Skills

LeadershipCoachingCommunicationCollaborationProblem-Solving

Industry Keywords

Patient Support Program (PSP)Specialty PharmacyInfusion ClinicHealthcare ComplianceQuality TrendsOperational RisksAdverse Event RecordsPrivacy AdherenceTraining Materials DevelopmentStakeholder Engagement

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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.