PV Safety Specialist

Location: Canada, home-based; candidates must reside in Canada

Salary: USD 80,000–106,600 annualized base pay

Company

IQVIA is a global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Coordinate local pharmacovigilance activities and oversee the safety profile of client product portfolios in collaboration with Global Safety.
• Manage pharmacovigilance cases from all sources and maintain the local Pharmacovigilance System Master File where applicable.
• Review local medical literature and process identified cases into Individual Case Safety Reports.
• Oversee safety reporting for interventional and non-interventional studies, Compassionate Use Programs, periodic reports, and local regulatory submissions.
• Supervise Risk Management Plans, additional Risk Minimization Measures, local signal detection, safety communications, and regulatory inquiries.
• Maintain the local pharmacovigilance quality system, agreements, training, archives, business continuity, audits, inspections, and CAPA implementation.

Requirements

• Experience managing pharmacovigilance activities and safety cases in accordance with internal procedures.
• Ability to work with local regulatory requirements, safety reporting processes, risk management plans, and regulatory authorities.
• Knowledge of pharmacovigilance quality systems, audits, inspections, CAPA plans, and data protection requirements.
• Ability to coordinate with Global Safety, Regulatory Affairs, local partners, service providers, and the EU QPPV Office.
• Residence in Canada is required for eligibility.

Culture & Benefits

• Home-based remote work within Canada.
• Full-time employment with health, wellness, and other benefits.
• Potential incentive plans, bonuses, or other additional compensation may be available depending on the position.
• Equal opportunity employment and reasonable accommodations throughout the hiring process.