PV and Quality Specialist
Oshawa, ON, Canada
Full Time
Entry Level
#LI-DNI
SPECIFIC WORKING CONDITIONS OR PHYSICAL REQUIREMENTS:
The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
OUR RECRUITMENT PROCESS:
Auxilium Health is an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment for all employees. Accommodations are available on request for candidates taking part in all aspects of the selection process.
*As our company continues to grow, we’re excited to add PV and Quality Specialist to our team.
JOB DESCRIPTION
POSITION PV and Quality Specialist
COMPANY AND LOCATION Auxilium Health, Head Office
EMPLOYMENT TYPE Full-time, Permanent
HOURS WORKED 37.5 hours per week, Monday-Friday, 9 am - 5pm
DEPARTMENT Patient Support Programs
REPORTING TO Director, Program Operations
DIRECT REPORTS No
LAST UPDATED May 13, 2026
SALARY RANGE: $55,000 to $65,000 (based on experience)
________________________________________________________________________________
COMPANY AND LOCATION Auxilium Health, Head Office
EMPLOYMENT TYPE Full-time, Permanent
HOURS WORKED 37.5 hours per week, Monday-Friday, 9 am - 5pm
DEPARTMENT Patient Support Programs
REPORTING TO Director, Program Operations
DIRECT REPORTS No
LAST UPDATED May 13, 2026
SALARY RANGE: $55,000 to $65,000 (based on experience)
________________________________________________________________________________
POSITION SUMMARY:
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.
GENERAL RESPONSIBILITIES & ESSENTIAL FUNCTIONS:
Pharmacovigilance (PV) & Compliance
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.
GENERAL RESPONSIBILITIES & ESSENTIAL FUNCTIONS:
Pharmacovigilance (PV) & Compliance
- Review, revise, and support execution of:
- Pharmacovigilance Agreements (PVAs)
- Safety Data Exchange Agreements (SDEAs)
- 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.
Pharmacovigilance & Audit Management
- 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
- 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
Adverse Event (AE) Management
- Oversee end-to-end AE reporting processes to ensure:
- Timely intake, documentation, and submission
- 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
Training & Compliance Oversight
- Ensure all employees complete mandatory annual PV training
- Manage onboarding PV training for new hires:
- Coordinate training delivery
- Track completion and maintain training records
- Maintain training documentation in audit-ready format
- Partner with internal teams to update training materials based on agreement or regulatory changes
Quality Assurance (QA)
- Conduct routine quality audits of patient files and program documentation
- Ensure completeness, accuracy, and compliance with:
- Internal workflows (WIs/SOPs)
- Client requirements
- Regulatory expectations
- Identify gaps, trends, and areas for improvement
- Provide recommendations and corrective actions to enhance quality and compliance
Operational Support & Collaboration
- 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 perspectiv
- Maintain clear and consistent documentation for audit and compliance purpose
- Support audit preparation and responses (internal and external audits)
Data & Reporting
- Track and report on PV and quality metrics, including:
- AE submission timelines
- Training completion rates
- Audit findings and trends
Provide insights and recommendations to improve compliance and operational performance
Other Duties
- Participate in ad hoc projects and continuous improvement initiatives
- Support broader PSP operations as required
EDUCATION
- Completion of post-secondary required
WHAT WE OFFER:
- Competitive compensation
- Healthcare Spending and Wellness Accounts
- Collaborative, diverse and inclusive culture
- Growth in an expanding and competitive market
SPECIFIC WORKING CONDITIONS OR PHYSICAL REQUIREMENTS:
- Office environment: a blend of sitting at a desk, standing, and working on a computer
- Hybrid working schedule
The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
OUR RECRUITMENT PROCESS:
- Application and Questionnaire - Candidates submit an application and complete the initial questionnaire.
- Pre-Screen Video Interview - Qualified candidates will be invited within one week to complete a short one-way video pre-screen.
- In-Person Interview - Shortlisted candidates will be invited to attend an in-person interview at our head office.
- Offer and Background Check - The successful candidate will be offered the position, pending a criminal background check and references.
Auxilium Health is an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment for all employees. Accommodations are available on request for candidates taking part in all aspects of the selection process.
*As our company continues to grow, we’re excited to add PV and Quality Specialist to our team.
Apply for this position
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