Project Manager, Patient Safety

🔥 35 minutes ago

🇨🇦 Canada – Remote

💵 $105k - $123k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👷‍♀️ Project Manager

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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 submissions • 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 • Travel 10–15%, including overnight stays as project needs and office location require • Perform other duties as needed or assigned

🎯 Requirements

• Non-degree plus 6–7 years' safety experience, or Associate degree (including RN) plus 5–6 years' safety experience, or BS/BA plus 4–5 years' safety experience, or MS/MA plus 2–3 years' safety experience (or 3–4 years' relevant experience), or PharmD plus 1–2 years' safety experience (or 2–3 years' relevant experience) • 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 skills • Client- and sponsor-facing skills • Excellent written, verbal and presentation skills • Strong negotiation and stakeholder management skills • Ability to collaborate across functions with internal and external stakeholders • Budget and financial management experience • Strong analytical and critical-thinking skills • Excellent organisation and attention to detail • Knowledge of worldwide pharmacovigilance regulations, GCP and ICH guidelines • Candidates must be legally authorized to work in Canada • Degrees in Biological Sciences, Pharmacy, Nursing, Life Sciences or Chemistry are preferred • Post-marketing safety experience, complex global or regional safety portfolio experience, aggregate reporting, risk management, mentoring experience, EudraVigilance certification and Medical Device Reporting knowledge are nice to have

🏖️ Benefits

• 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 • Collaborative culture • Opportunities for professional growth

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