Senior/Principal Drug Safety Specialist

🔥 26 minutes ago

🇵🇭 Philippines – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Perform and potentially oversee day-to-day Pharmacovigilance activities in a highly regulated environment • Collect, monitor, assess, evaluate, research and track safety information • Participate in on-call duties for specific projects to ensure 24-hour case-intake coverage • Lead activities and assist in developing program and departmental procedural documents • Prepare for and attend audits • Mentor less experienced staff • Review regulatory and pharmacovigilance publications and information sources • 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 safety committees • Present at client and investigator meetings • Review metrics and budget considerations • Collaborate with project teams, clients, investigators, adverse-event reporters and third-party vendors

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous relevant experience • Equivalent combination of education, training and/or directly related experience may be considered • Thorough understanding of pathophysiology and disease processes • Strong knowledge of relevant therapeutic areas for adverse-event processing • Excellent critical thinking and problem-solving skills • Proficiency in complex clinical study administration, budget activities and forecasting • Excellent oral and written communication skills, including paraphrasing • Good command of English and ability to translate information into local language where required • Computer literacy and ability to work within multiple databases • Proficiency in Microsoft Office, including Outlook, Word and Excel • Thorough understanding of global regulatory requirements and procedural compliance • Ability to manage and prioritize varied tasks and meet strict deadlines with limited supervision • Strong attention to detail • Ability to maintain a positive and professional demeanor in challenging circumstances • Ability to work effectively within a team • Occasional domestic and/or international travel required

🏖️ Benefits

• Collaboration and development opportunities • Opportunity to contribute to patient safety and scientific excellence • Global team environment • Occasional domestic and international travel

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