Safety Lead

Role Overview

We are partnering with a client seeking a Safety Lead based in the United States to provide expert safety and pharmacovigilance guidance supporting clinical research initiatives. This position ensures regulatory compliance with global safety standards across clinical programs, overseeing adverse event management, reporting, documentation, and quality control.

The successful candidate will act as a strategic partner collaborating with clients, internal teams, vendors, and clinical sites, offering subject matter expertise throughout the clinical trial lifecycle. This role enables the individual to influence safety approaches, optimize processes, mentor team members, and contribute to delivering clinical trials that prioritize patient safety and regulatory success globally.

Key Responsibilities

• Support safety-related activities for projects including planning meetings, governance, and teleconferences.
• Develop, manage, and refine safety management plans, operational workflows, and industry best practice procedures.
• Oversee case management for Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) from initial intake to regulatory submission.
• Collaborate with sponsors, vendors, and study teams to design safety data collection tools, reporting frameworks, and quality assurance processes.
• Engage in setting up and maintaining safety databases and ensuring data integrity.
• Review and control quality of safety documentation, regulatory submissions, and safety reports.
• Create and update safety reporting guidelines, medical coding instructions, and training materials.
• Lead efforts to develop and continuously improve standard operating procedures and departmental workflows.
• Act as a key clinical safety expert, providing subject matter expertise and guidance.
• Provide training, mentorship, and coaching to Safety Specialists and other personnel.
• Support readiness activities for audits and inspections, including Corrective and Preventive Action (CAPA) follow-up.
• Participate in client presentations and contribute to business development efforts.
• Manage safety-focused standalone projects and contribute to cross-functional initiatives.
• Monitor and coordinate query resolution related to safety data and events.
• Advise on regulatory responses regarding safety and pharmacovigilance issues.
• Assist internal teams and clients with specialized safety assessments and reviews.

Candidate Requirements

• Bachelor’s degree in an applicable discipline is mandatory.
• Minimum of 10 years' experience in clinical safety roles, with at least 5 years focused on pharmacovigilance.
• Healthcare professional credentials (such as nursing or pharmacy degree) preferred.
• Practical experience working with global safety databases, SAE case handling, and safety report generation.
• Proficient knowledge of MedDRA and WHODrug coding terminologies.
• In-depth understanding of FDA regulations, ICH guidelines, and worldwide pharmacovigilance standards.
• Track record supporting clinical trial safety reporting, regulatory audit readiness, and BLA/NDA submission inspections.
• Strong communication skills to convey complex clinical and regulatory concepts effectively.
• Demonstrated analytical thinking, judgment, and problem-solving capabilities.
• Ability to operate efficiently in a dynamic, fast-paced work environment with flexibility and initiative.
• Excellent organizational abilities to prioritize multiple competing tasks.
• Experience in pharmaceutical or Clinical Research Organization (CRO) settings advantageous.
• Project management experience is a plus.

Compensation and Benefits

• Annual salary range from $110,700 to $166,100 USD.
• Eligibility for discretionary annual bonuses.
• Comprehensive health insurance coverage.
• Retirement savings plans.
• Life and disability insurance benefits.
• Paid leave including vacation and sick days.
• Parental leave available.
• Opportunity for remote work flexibility.
• Chance to engage in innovative clinical research projects.
• Support for professional development and career growth.