Safety Reporting Specialist

About the role

As a Safety Reporting Specialist, you will support critical pharmacovigilance and clinical research activities by coordinating the preparation, submission, and tracking of safety reports. You will help ensure that regulatory reporting obligations are met accurately and within established timelines across multiple countries.

What you'll do

• Safety Report Preparation and Submission: Receive, prepare, and submit expedited and periodic safety reports to the appropriate regulatory authorities, clients
• Submission Tracking and Documentation: Monitor all safety report submissions, maintain accurate submission records, and retain proof of submission
• Promptly escalate potential delays, quality concerns, and reporting issues to the assigned lead or line manager
• Opportunities may include managing smaller projects independently
• Cross-Functional Collaboration: Liaise with relevant internal teams and stakeholders to coordinate reporting tasks, resolve operational questions

What you need

• 0–2 yrs of experience
• Excel
• Reporting
• Documentation
• Coordination
• MS Office
• Clinical research
• Any graduate

Good to have

• Pharmacovigilance
• Medication administration
• SOP writing