Safety Reporting Specialist

Role & Responsibilities
• Receive, prepare, and submit Individual Case Safety Reports (ICSRs) to global regulatory authorities
• Ensure all safety reports comply with country legislation and regulatory timelines
• Lead large-scale safety reporting projects and monitor submission performance
• Contribute to the development and continuous improvement of SOPs and procedural documents
• Collaborate with internal teams on safety reporting activities
• Act as the primary point of contact for safety reporting projects
• Mentor and guide new team members and junior colleagues
• Produce safety metrics and support limited financial project activities
• Participate in internal and external meetings related to pharmacovigilance operations

Qualification
• Bachelor’s degree in Pharmacy, Life Sciences, or a related discipline

Experience
• Minimum 2+ years of experience in safety reporting or pharmacovigilance
• Strong understanding of global safety reporting requirements
• Proven skills in ICSR submissions, regulatory timelines, and safety reporting processes

Skills
• Global safety reporting and pharmacovigilance compliance
• ICSR submission and regulatory timelines management
• SOP development and cross-functional collaboration
• Proficiency in Microsoft Office and safety databases
• Strong attention to detail and multi-tasking ability
• Ability to influence and collaborate across teams

Benefits & Work Environment
• Fully remote work model
• Standard Monday–Friday schedule
• Exposure to global pharmacovigilance projects
• Opportunity to work with senior international stakeholders
• Career growth in a regulated, high-impact safety environment

About the Company
• Thermo Fisher Scientific is a leading global life sciences organization, providing innovative solutions and cutting-edge technology in the fields of biotechnology, life sciences, and drug safety.