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:
- 2+ years of project management experience.
Essential skills and experience:
- 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.
Physical Demands / Work Environment
- Office environment.
- Travel of 10–15%, including overnight stays as project needs and office location require.
What We Offer
- Be at the forefront of drug safety and clinical research in a global, growth-focused organisation.
- Work with talented professionals and senior leaders to shape the future of clinical research.
- Enjoy a collaborative culture, competitive benefits and opportunities for professional growth.
Candidates must be legally authorized to work in Canada. Fortrea is unable to provide visa or work permit sponsorship of any kind for this position.
Pay Range: CAD 105,000-123,000
Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.
Application Deadline: 11/11/26
Learn more about our EEO & Accommodations request here.