Project Manager, Patient Safety

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

📋 Description

• Lead and manage safety projects on a global or regional scale.

• Streamline communications and processes effectively.

• Supervise the processing of adverse events, which includes data entry, MedDRA coding, narrative writing, expectedness assessment, and medical review.

• Manage expedited safety reports, covering triage, quality review, EudraVigilance activities, and timely submissions.

• Conduct or oversee quality reviews, signal detection, trend identification, and aggregate reporting.

• Develop Safety Management Plans, reconciliation plans, and monthly status updates.

• Monitor deliverables to ensure alignment with contract expectations.

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

• Serve as the safety lead for sponsors in client meetings, audits, and safety committees, including Data Safety Monitoring Boards (DSMBs).

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

• Contribute to the development of Standard Operating Procedures (SOPs) and work instructions.

• Willingness to travel 10–15%, which may include overnight stays based on project requirements and office location.

• Perform additional duties as necessary or as assigned.

⛳️ Requirements

• Non-degree with 6–7 years of safety experience, or an Associate degree (including RN) with 5–6 years of safety experience, or a BS/BA with 4–5 years of safety experience, or an MS/MA with 2–3 years of safety experience (or 3–4 years of relevant experience), or a PharmD with 1–2 years of safety experience (or 2–3 years of relevant experience).

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

• A minimum of 2 years of project management experience.

• Extensive experience leading safety projects and independently managing a portfolio of projects.

• Strong background in clinical trial safety and a solid understanding of pharmacovigilance requirements.

• Exceptional project management and safety leadership abilities.

• Proficient in client and sponsor interactions.

• Outstanding written, verbal, and presentation skills.

• Excellent negotiation and stakeholder management capabilities.

• Ability to work collaboratively across functions with both internal and external stakeholders.

• Experience with budget and financial management.

• Strong analytical and critical-thinking skills.

• Excellent organizational skills and attention to detail.

• Familiarity with global pharmacovigilance regulations, Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines.

• Candidates must be legally authorized to work in Canada.

• Preferred degrees include Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry.

• Additional qualifications such as post-marketing safety experience, complex global or regional safety portfolio experience, aggregate reporting, risk management, mentoring experience, EudraVigilance certification, and knowledge of Medical Device Reporting are desirable.

🏝️ Benefits

• Comprehensive medical benefits.

• Dental benefits.

• Vision benefits.

• Life insurance.

• Short-term disability (STD).

• Long-term disability (LTD).

• 401(k) retirement plan.

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

• Company bonus where applicable.

• Collaborative work culture.

• Opportunities for professional development and growth.