Project Manager, Patient Safety

This is a fully remote position, open to applicants in Canada.

📋 Description

• Direct and oversee global or regional safety initiatives.

• Streamline communications and processes.

• Supervise adverse event processing, including data entry, MedDRA coding, narrative writing, expectedness assessment, and medical reviews.

• Manage expedited safety reports, encompassing triage, quality checks, EudraVigilance activities, and timely submissions to clients and regulatory bodies.

• Conduct or supervise quality reviews, signal detection, trend identification, and comprehensive reporting.

• Develop Safety Management Plans, reconciliation strategies, and monthly progress reports.

• Track deliverables in relation to contractual expectations.

• Identify out-of-scope tasks and assist in estimating time and costs.

• Serve as the safety lead facing sponsors in client meetings, audits, and safety committees, including DSMBs.

• Provide training, mentorship, and support to team members.

• Assist in the creation of SOPs and operational instructions.

• Execute additional responsibilities as required or assigned.

⛳️ Requirements

• Non-degree candidates must have 6–7 years of safety experience.

• Associate degree holders (including RN) should have 5–6 years of safety experience.

• Candidates with a BS/BA should possess 4–5 years of safety experience.

• MS/MA degree holders must have 2–3 years of safety experience, or 3–4 years of relevant experience.

• PharmD candidates should have 1–2 years of safety experience, or 2–3 years of relevant experience.

• Degrees in Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry are preferred.

• Equivalent experience may be accepted in place of educational qualifications.

• At least 2 years of project management experience is required.

• Extensive experience in leading safety projects and independently managing a project portfolio is essential.

• Strong background in clinical trial safety and knowledge of pharmacovigilance regulations is crucial.

• Excellent project management and safety leadership abilities are necessary.

• Must possess client and sponsor-facing skills.

• Exceptional written, verbal, and presentation abilities are required.

• Strong skills in negotiation and stakeholder management are important.

• Ability to collaborate effectively with internal and external stakeholders across functions is needed.

• Proficient budget and financial management skills are required.

• Strong analytical and critical-thinking abilities are essential.

• Excellent organizational skills and attention to detail are necessary.

• Good understanding of global pharmacovigilance regulations, GCP, and ICH guidelines is preferred.

• Candidates must have legal authorization to work in Canada.

• Fortrea is unable to provide visa or work permit sponsorship.

• Experience in post-marketing safety is a plus.

• Experience in supporting complex global or regional safety portfolios is advantageous.

• Familiarity with aggregate reporting, risk management, and broader pharmacovigilance is desirable.

• Experience in mentoring less-experienced colleagues is beneficial.

• EudraVigilance certification and knowledge of Medical Device Reporting are appreciated.

🏝️ Benefits

• Comprehensive medical coverage.

• Dental insurance.

• Vision coverage.

• Life insurance policy.

• Short-term disability (STD) coverage.

• Long-term disability (LTD) coverage.

• 401(k) retirement plan.

• Paid time off (PTO) or flexible time off (FTO) options.

• Company bonuses where applicable.

• Opportunities for professional advancement.

• A collaborative working environment.

• Competitive benefits package.

• A global organization focused on growth.

• Travel requirements of 10–15%, including overnight stays as dictated by project needs and office locations.