Project Manager, Patient Safety

Fortrea

. Lead and manage global or regional safety projects .

Posted 11/9/2026full-timeRemote • CanadaJuniorMid-Level💰 CA$105,000 - CA$123,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in leading safety projects and managing safety portfolios, with a strong understanding of pharmacovigilance regulations and clinical trial safety. Capable of effective communication and collaboration with clients and stakeholders while ensuring compliance with GCP and ICH guidelines.

Highest-signal resume keywords

Safety Project ManagementPharmacovigilance ExpertiseClient-Facing SkillsBudget ManagementAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Adverse Event ProcessingMedDRA CodingQuality ReviewSignal DetectionAggregate ReportingEudraVigilance ActivitiesSafety Management PlansTrend RecognitionData EntryMedical Review

Soft Skills

LeadershipCollaborationNegotiationAttention to DetailCommunication Skills

Certifications & Qualifications

EudraVigilance Certification

Industry Keywords

Pharmacovigilance RegulationsGCP GuidelinesICH GuidelinesClinical Trial SafetyPost-Marketing Safety

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead and manage global or regional safety projects
Harmonise communications and processes
Oversee adverse event processing, including data entry, MedDRA coding, narratives, expectedness assessment and medical review
Oversee expedited safety reports, 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
Contribute to SOPs and work instructions
Perform other duties as needed or assigned

Requirements

What you’ll need

Non-degree plus 6–7 years' safety experience
Associate degree (including RN) plus 5–6 years' safety experience
BS/BA plus 4–5 years' safety experience
MS/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
2+ years of project management experience
Significant experience leading safety projects and independently managing a portfolio of projects
Significant clinical trial safety experience and understanding of pharmacovigilance requirements
Strong project management and safety leadership
Client and sponsor-facing skills
Excellent written, verbal and presentation skills
Strong negotiation and stakeholder management
Ability to collaborate across functions with internal and external stakeholders
Strong budget and financial management
Strong analytical and critical-thinking skills
Excellent organisation and attention to detail
Good knowledge of worldwide pharmacovigilance regulations, GCP and ICH guidelines
Candidates must be legally authorized to work in Canada
Fortrea is unable to provide visa or work permit sponsorship
Post-marketing safety experience is nice to have
Experience supporting complex global or regional safety portfolios is nice to have
Exposure to aggregate reporting, risk management and broader pharmacovigilance is nice to have
Experience mentoring less-experienced colleagues is nice to have
EudraVigilance certification and knowledge of Medical Device Reporting are nice to have

Benefits

Comp & perks

Comprehensive medical benefits
Dental benefits
Vision benefits
Life insurance
Short-term disability (STD)
Long-term disability (LTD)
401(k)
Paid time off (PTO) or flexible time off (FTO)
Company bonus where applicable
Opportunities for professional growth
Collaborative culture
Competitive benefits
Global, growth-focused organisation
Travel of 10–15%, including overnight stays as project needs and office location require