Safety Specialist

• Perform and potentially oversee day-to-day Pharmacovigilance activities in a highly regulated, deadline-driven environment
• Collect, monitor, assess, evaluate, research, and track safety information
• Collaborate with project team members, clients, investigators, adverse-event reporters, and third-party vendors
• Participate in on-call duties for specific projects to ensure 24-hour coverage for case intake from investigative sites
• Operate in a lead capacity and assist with developing program and departmental procedural documents
• Prepare for and attend audits
• Mentor less experienced staff
• Review regulatory/pharmacovigilance publications and information sources to stay current on regulations, practices, procedures, and proposals
• Maintain medical understanding of applicable therapeutic areas and disease states
• Review cases for quality, consistency, and accuracy, including peer reports
• Coordinate routine project implementation, including Clinical Trials and Endpoint Assessment/Data Safety Monitoring Committees
• Present at client and investigator meetings
• Review metrics and budget considerations

Safety Specialist jobs in Philippines

Senior Drug Safety Specialist – Night Shift