4h ago

Safety Lead

United StatesRemoteFull-timelead

OtherSafety

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Quick Summary

Overview

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Safety Lead based in United States .

Technical Tools

OtherSafety

This is a senior clinical safety and pharmacovigilance role supporting complex clinical research projects in a fully remote environment.
You will provide safety expertise across study planning, implementation, case management, regulatory reporting, and ongoing project oversight.
The role combines strategic leadership with hands-on involvement in safety processes, documentation, quality control, and risk management.
You will collaborate with sponsors, vendors, study teams, and internal stakeholders to establish effective safety collection and reporting processes.
The position also involves mentoring Safety Specialists, supporting audits and inspections, and contributing to cross-functional initiatives.
Strong regulatory knowledge and the ability to communicate complex clinical safety matters clearly will be essential to success.
This opportunity is suited to an experienced healthcare professional who can work independently, manage competing priorities, and provide sound judgment in a fast-paced environment.

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

~1 min read

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.