Clinical Safety Specialist

@ Johnson & Johnson MedTech

About Johnson & Johnson MedTech

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. With expertise in Innovative Medicine and MedTech, we deliver breakthroughs that shape the future of healthcare.

About the Cardiovascular Team

Fueled by innovation at the intersection of biology and technology, our Cardiovascular team is dedicated to developing smarter, less invasive, and personalized treatments for heart recovery, electrophysiology, and stroke.

Role Overview: Clinical Safety Specialist

This remote role based in the continental USA is responsible for implementing and executing clinical trial safety activities for clinical research programs. The role involves managing safety processes, performing medical reviews of safety events, and ensuring timely regulatory reporting.

Key Responsibilities

• Manage safety related clinical trial activities for assigned studies.
• Develop and implement study-specific Safety Management Plans and Case Report Forms.
• Conduct ongoing medical reviews of adverse events and safety data.
• Manage safety queries, event reconciliation, and regulatory reporting.
• Support review and execution of standard operating procedures and process improvements.

Qualifications

• Bachelor’s Degree in nursing, healthcare, or life sciences.
• Minimum 5 years' experience in clinical research safety processes.
• Experience in managing safety events and clinical trial databases.
• Knowledge of regulatory standards including 21CFR803, 21CFR812, ISO 14155, EU MDR, etc.
• Strong written/oral communication and analytical skills.

Key skills/competency

Clinical safety, Clinical trials, Regulatory reporting, Adverse events, Medical review, Safety management plan, Case report forms, Quality assurance, MedTech, Clinical research