PV and Quality Specialist

Auxilium Health•Oshawa, ON

2d•CA$55,000 - CA$65,000•Hybrid

About The Position

The Pharmacovigilance (PV) and Quality Associate is responsible for supporting and maintaining all pharmacovigilance and quality assurance activities across Auxilium Health’s Patient Support Programs (PSPs). This role ensures compliance with regulatory requirements, client agreements, and internal standards related to adverse event reporting, safety data exchange, and quality management. The incumbent will act as the primary point of contact for PV and quality-related processes, working cross-functionally with internal teams and pharmaceutical manufacturer partners to ensure accurate, timely, and compliant program delivery.

Requirements

Completion of post-secondary education.

Responsibilities

Review, revise, and support execution of Pharmacovigilance Agreements (PVAs), Safety Data Exchange Agreements (SDEAs), and Quality Agreements (as applicable).
Liaise with manufacturers to align on PV requirements, reporting timelines, and compliance expectations.
Ensure operational adherence to all PV-related agreements and regulatory obligations.
Maintain up-to-date knowledge of applicable PV regulations and industry best practices.
Lead PV audit preparations.
Support with the coordination and execution of all on-site and virtual pharmacovigilance audits, including audit preparation, documentation review, and stakeholder coordination.
Serve as the primary point of contact during PV audits for communications, document submissions and key follow-up requests.
Assist with presenting processes, systems, and compliance practices to internal and external stakeholders during PV audits.
Ensure ongoing audit readiness across all programs, including maintaining complete, accurate, and inspection-ready documentation.
Manage all audit activities end-to-end, including preparation of required materials and evidence, participation in and facilitation of audit sessions, and timely response to audit inquiries and requests.
Collaborate with post-audit activities, including tracking, documenting, and driving resolution of audit findings through corrective and preventive actions (CAPAs).
Partner with internal teams and manufacturers to ensure alignment and timely closure of audit outcomes.
Oversee end-to-end AE reporting processes to ensure timely intake, documentation, and submission, and compliance with manufacturer and regulatory reporting timelines.
Conduct internal and external AE reconciliations (qualitative and quantitative).
Investigate discrepancies and implement corrective actions as needed.
Maintain accurate documentation and audit trails for all AE-related activities.
Ensure all employees complete mandatory annual PV training.
Manage onboarding PV training for new hires, including coordinating training delivery, tracking completion, and maintaining training records.
Maintain training documentation in audit-ready format.
Partner with internal teams to update training materials based on agreement or regulatory changes.
Conduct routine quality audits of patient files and program documentation.
Ensure completeness, accuracy, and compliance with internal workflows (WIs/SOPs), client requirements, and regulatory expectations.
Identify gaps, trends, and areas for improvement.
Provide recommendations and corrective actions to enhance quality and compliance.
Work closely with Operations, Program Managers, and Leadership to ensure alignment between PV, quality, and program execution.
Support onboarding of new manufacturer programs from a PV/QA perspective.
Maintain clear and consistent documentation for audit and compliance purposes.
Support audit preparation and responses (internal and external audits).
Track and report on PV and quality metrics, including AE submission timelines, training completion rates, and audit findings and trends.
Provide insights and recommendations to improve compliance and operational performance.
Participate in ad hoc projects and continuous improvement initiatives.
Support broader PSP operations as required.