Safety Lead

Accountabilities:

• • Lead and oversee safety activities across clinical projects, including project kickoffs, study meetings, governance meetings, and client interactions.
  • Develop and review project-specific safety management, reporting, and medical coding plans, ensuring alignment with applicable requirements.
  • Oversee serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) case management from intake through regulatory reporting.
  • Partner with sponsors, vendors, study teams, and internal stakeholders to design and implement effective safety collection tools, processes, and reporting systems.
  • Participate in the assessment and setup of safety databases and oversee processes for capturing, reviewing, and reporting safety data.
  • Conduct quality control and review of safety documents, reports, training materials, and other pharmacovigilance deliverables.
  • Develop and maintain standard operating procedures, work instructions, and other departmental safety processes.
  • Provide subject matter expertise on clinical safety and pharmacovigilance matters to clients, project teams, and departmental colleagues.
  • Provide training, coaching, and mentorship to Safety Specialists while supporting departmental resource management and oversight.
  • Support audits, inspection readiness, investigator meetings, audit preparation, and regulatory agency inspections, including activities related to BLA or NDA approval inspections.
  • Participate in CAPA management and support the development and implementation of corrective and preventive actions.
  • Support bid defenses, client proposals, and safety-related project discussions by providing technical and operational expertise.
  • Lead standalone safety projects and contribute to cross-functional initiatives and departmental improvements.
  • Oversee SAE/AESI queries, tracking, escalation, and resolution, and provide input on responses to regulatory agency questions related to safety and pharmacovigilance.
  • Identify opportunities to strengthen safety processes, systems, and delivery while ensuring high standards of quality and compliance.

  Requirements:

  • Bachelor’s degree in a relevant field, with a healthcare professional background required.
  • 10+ years of clinical safety experience and at least 5 years of pharmacovigilance experience.
  • Hands-on experience with global safety databases, SAE case processing, and safety report generation.
  • Strong knowledge of MedDRA, WHODrug, FDA safety regulations, ICH guidelines, and applicable global regulatory requirements.
  • Demonstrated understanding of clinical trial safety reporting and pharmacovigilance processes across relevant regulatory environments.
  • Experience supporting internal audits, inspection readiness, and regulatory agency inspections within clinical research environments.
  • Ability to understand complex clinical and safety issues and communicate them clearly and scientifically to technical and non-technical audiences.
  • Excellent written, verbal, analytical, organizational, and problem-solving skills.
  • Strong judgment and the ability to make sound decisions in complex or high-stakes situations.
  • Ability to work effectively in a fast-paced and evolving environment while remaining flexible, proactive, resourceful, and efficient.
  • Experience collaborating with sponsors, vendors, study teams, and other cross-functional stakeholders.
  • Experience with project management and leadership responsibilities is highly desirable.
  • A nursing or pharmacy degree is an asset.
  • Previous experience within a CRO or pharmaceutical company is preferred.

  Benefits:

  • Fully remote opportunity based in Canada.
  • Senior-level position with significant responsibility across clinical safety and pharmacovigilance programs.
  • Opportunity to serve as a safety subject matter expert and influence departmental standards and processes.
  • Exposure to global clinical development programs, sponsors, vendors, and regulatory environments.
  • Opportunities to mentor Safety Specialists and contribute to professional and departmental development.
  • Involvement in strategic initiatives, client engagements, audits, inspections, and complex safety projects.
  • Collaborative environment supporting cross-functional work and continuous improvement.
  • Compensation and overall employment terms are determined based on qualifications, experience, market considerations, and the requirements of the role.