Project Manager, Patient Safety - Remote, Canada

Fortrea; Toronto; Remote; CAD 105,000 - 123,000; Full time

Benefits offered by this job

Medical benefits

Vision & Dental

401(k) Retirement plan

Paid time off

Job summary

Fortrea is seeking a Project Safety Lead to oversee global safety projects, manage adverse event processing, and ensure timely, regulatory-compliant deliverables for sponsors.

You will lead safety portfolios, mentor teams, and contribute to SOPs while maintaining strong client relationships and budgets. Travel up to 10–15% may be required as project needs dictate.

Qualifications

• Significant experience leading safety projects and independently managing a portfolio.
• Strong project management and safety leadership across deliverables and budgets.
• Experience with pharmacovigilance requirements and regulatory expectations.

Responsibilities

• Lead and manage global safety projects and client communications.
• Oversee adverse event processing and expedited reports.
• Prepare safety management plans and monthly status reports.
• Mentor colleagues and contribute to SOPs and work instructions.

Skills

Project management

Safety leadership

Sponsor-facing skills

Stakeholder management

Pharmacovigilance knowledge

Analytical thinking

Education

BS/BA in life sciences

MS/MA in life sciences

PharmD or RN with safety experience

Tools

GxP / pharmacovigilance regulations

Job description

Project Safety Lead, Product Safety Services (PSS)Lead global drug safety projects, manage your own project portfolio and be the trusted safety partner our sponsors rely on. In this role you will oversee adverse event processing, expedited reporting and quality, delivering compliant, on-time results for clients and regulators worldwide.This role is for upcoming future opportunities that may arise at FortreaKey ResponsibilitiesLead and manage global or regional safety projects, harmonising communications and processes.Oversee adverse event processing from any source, including data entry, MedDRA coding, narratives, expectedness assessment and medical review.Oversee expedited safety reports (ESRs), including triage, quality review, EudraVigilance activities and on-time submission to clients and regulators.Perform or oversee quality review, signal detection, trend recognition and aggregate reporting.Prepare Safety Management Plans, reconciliation plans and monthly status reports.Monitor deliverables against contract assumptions, flag out-of-scope work and contribute to time and cost estimates.Act as the sponsor-facing safety lead in client meetings, audits and safety committees (including DSMBs).Train, mentor and support colleagues, and contribute to SOPs and work instructions.Other duties as needed or assigned.Required QualificationsEducation and safety experience (minimum), one of:Non-degree plus 6–7 years' safety experienceAssociate degree (including RN) plus 5–6 years' safety experienceBS/BA plus 4–5 years' safety experienceMS/MA plus 2–3 years' safety experience (or 3–4 years' relevant experience)PharmD plus 1–2 years' safety experience (or 2–3 years' relevant experience)Degrees in Biological Sciences, Pharmacy, Nursing, Life Sciences or Chemistry are preferred. Equivalent experience may be considered in lieu of education requirements.In addition, all candidates must have:2+ years of project management experience.Essential skills and experience:Significant experience leading safety projects and independently managing a portfolio of projects.Strong project management and safety leadership, overseeing delivery, priorities, risks and competing demands across projects.Significant clinical trial safety experience and a sound understanding of pharmacovigilance requirements.Strong client and sponsor-facing skills: listening carefully, understanding sponsor needs and giving clear, pragmatic guidance and strategic direction.Excellent written, verbal and presentation skills, with strong negotiation and stakeholder management.Proven ability to collaborate across functions with internal and external stakeholders.Strong budget and financial management, including oversight of deliverables against contractual assumptions and spotting out-of-scope work or budget risk.Strong analytical and critical-thinking skills, anticipating issues, evaluating options and supporting decisions.Excellent organisation and attention to detail, with a strategic view of project and portfolio priorities.Good knowledge of worldwide pharmacovigilance regulations, GCP and ICH guidelines.Nice to have:Post-marketing safety experience in addition to clinical trial safety.Experience supporting complex global or regional safety portfolios.Exposure to aggregate reporting, risk management and broader pharmacovigilance.Experience mentoring less-experienced colleagues.EudraVigilance certification and knowledge of Medical Device Reporting.Physical Demands / Work EnvironmentOffice environment.Travel of 10–15%, including overnight stays as project needs and office location require.What We OfferBe at the forefront of drug safety and clinical research in a global, growth-focused organisation.Work with talented professionals and senior leaders to shape the future of clinical research.Enjoy a collaborative culture, competitive benefits and opportunities for professional growth.Candidates must be legally authorized to work in Canada. Fortrea is unable to provide visa or work permit sponsorship of any kind for this position.Pay Range: CAD 105,000-123,000Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.Application Deadline: 11/11/26Learn more about our EEO & Accommodations request here .