Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Join Us as a Senior Safety Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As a Senior Safety Specialist, you'll perform and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. Your responsibilities will include, but are not limited to, the collection, monitoring, assessment, evaluation, research, and tracking of safety information. You will effectively collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors.

What You’ll Do:
• Works independently to perform day-to-day PV activities.



May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
• Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less experienced staff.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
• Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
• Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations

Education and Experience Requirements:
• Bac

📌 Sr Safety Specialist (México)
🏢 Thermo Fisher Scientific
📍 México