Project Safety Lead, Product Safety Services (PSS)

As a Project Safety Lead, Product Safety Services (PSS) at Fortrea, you will lead global drug safety projects, manage your own project portfolio, and be the trusted safety partner our sponsors rely on. Your responsibilities will include: Leading and managing global or regional safety projects, harmonising communications and processes. Overseeing adverse event processing from any source, including data entry, MedDRA coding, narratives, expectedness assessment, and medical review. Overseeing expedited safety reports (ESRs), including triage, quality review, EudraVigilance activities, and on-time submission to clients and regulators. Performing or overseeing quality review, signal detection, trend recognition, and aggregate reporting. Preparing Safety Management Plans, reconciliation plans, and monthly status reports. Monitoring deliverables against contract assumptions, flagging out-of-scope work, and contributing to time and cost estimates. Acting as the sponsor-facing safety lead in client meetings, audits, and safety committees (including DSMBs). Training, mentoring, and supporting colleagues, and contributing to SOPs and work instructions. To qualify, you will need: 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. 2+ years of project management experience. Essential skills and experience include: 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. In terms of physical demands and work environment: Office environment. Travel of 10–15%, including overnight stays as project needs and office location require. We offer: Competitive salary: CAD 105,000-123,000 Comprehensive benefits, including Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable Job Data by YubHub .