Clinical Safety Specialist

What You'll Do:

• Review, assess, and process Adverse Events and Serious Adverse Events from clinical studies.
• Evaluate source documentation for completeness, accuracy, and consistency.
• Identify missing or incomplete safety information and coordinate follow-up activities.
• Enter and maintain safety data within clinical trial databases in accordance with established timelines.
• Collaborate with internal teams and clinical sites to resolve data discrepancies and outstanding safety items.
• Track case progress and reporting deadlines to ensure regulatory compliance.
• Prepare safety narratives and support the submission of required safety reports.
• Maintain accurate, organized, and inspection-ready safety documentation.
• Prepare materials for safety review meetings and support meeting coordination activities.
• Document and distribute meeting minutes, follow-up communications, and action items.
• Draft and distribute site follow-up correspondence related to safety reporting activities.
• Monitor reporting timelines and ensure all regulatory obligations are met.
• Ensure adherence to company procedures, ICH-GCP guidelines, and applicable regulatory requirements.
• Support internal audits, quality reviews, and regulatory inspections.
• Identify and elevate potential compliance concerns and data quality issues.
• Contribute to process improvements that enhance safety operations and compliance effectiveness.
• Partner closely with Clinical Operations, Regulatory Affairs, Data Management, and other cross-functional teams.
• Communicate proactively regarding case status, timelines, and emerging issues.
• Assist with training and education related to safety reporting processes and expectations.
• Coordinate safety meetings and maintain tracking tools, calendars, and milestone schedules.

Qualifications

• Bachelor's degree in Nursing (RN), Life Sciences, Pharmacy, Public Health, or a related discipline.
• 3-5 years of experience in clinical research, clinical safety, pharmacovigilance, healthcare quality, or a related field.
• Working knowledge of ICH-GCP guidelines and clinical trial safety reporting requirements.
• Experience utilizing electronic clinical trial or safety databases.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.

Base salary range: $90,000 - $115,000 (potentially flexible) annually, plus bonus, stock options and a comprehensive benefits package that includes medical, dental, vision, retirement savings, paid time off, paid holidays, and parental leave.