Project Manager, Patient Safety - Remote, Canada

About this role

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 Fortrea*

Key Responsibilities

• Lead 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 Qualifications

*Education and safety experience (minimum), one of:*

• 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.

*In addition, all candidates must have:*

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