Safety Lead

Accountabilities:

• Lead project-specific safety activities, including kick-off meetings, internal study meetings, governance meetings, safety planning, and safety budget reviews.
• Develop and manage safety management plans, safety reporting plans, medical coding plans, standard operating procedures, and work instructions.
• Oversee serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) case management from intake through regulatory reporting.
• Interface with sponsors, vendors, and internal teams to support the design and implementation of safety collection tools, processes, and reporting systems.
• Participate in the assessment and setup of safety databases used to capture and manage SAE data.
• Perform quality control of safety documentation and reports and support the generation, tracking, and resolution of SAE/AESI queries.
• Provide oversight of query resolution and escalation activities while supporting timely issue management.
• Prepare or review safety training materials and provide ongoing training, mentorship, and subject matter expertise to Safety Specialists.
• Participate in audits, audit preparation, investigator meetings, CAPA management, inspection readiness, and regulatory agency inspection support.
• Provide safety and pharmacovigilance input for regulatory agency questions and assist with reviewing responses related to safety activities.
• Support client and departmental safety reviews and other specialized safety services.
• Participate in bid defenses for existing and prospective clients and support departmental resource and operational management.
• Serve as project manager for standalone safety projects and lead departmental initiatives and cross-functional development activities.

Requirements

• Bachelor’s degree (BA/BS) is required.
• 10+ years of clinical safety experience and at least 5 years of pharmacovigilance (PV) experience.
• Healthcare professional background is required.
• Hands-on experience with global safety databases, SAE case processing, and safety report generation.
• Working knowledge of MedDRA and WHODrug.
• Strong knowledge of FDA safety regulations, ICH guidelines, and global regulatory requirements governing clinical trial safety reporting and processing.
• Demonstrated experience supporting internal audits, inspection readiness, and regulatory agency inspections for clinical trials, including BLA or NDA approval inspections.
• Excellent written and verbal communication skills, with strong analytical abilities.
• Excellent judgment and the ability to communicate complex clinical issues in a scientifically sound and understandable manner.
• Ability to work effectively in a fast-paced and innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Nursing or pharmacy degree is preferred.
• Previous experience within a Contract Research Organization (CRO) or pharmaceutical company is preferred.
• Project management experience is preferred.
• Candidates must be legally authorized to work in Canada without employer sponsorship.

Benefits

• Fully remote work model in Canada.
• Opportunity to lead clinical safety and pharmacovigilance activities across complex clinical research projects.
• Broad exposure to global safety databases, regulatory reporting, clinical trial safety, and pharmacovigilance processes.
• Opportunity to provide subject matter expertise and mentor Safety Specialists.
• Involvement in audits, inspection readiness, regulatory interactions, and cross-functional initiatives.
• Leadership opportunities across standalone safety projects and departmental development activities.
• Collaborative environment involving sponsors, vendors, study teams, and cross-functional stakeholders.