Senior Safety Specialist

🔥 2 hours ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

✨ Safety Specialist

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform and potentially oversee day-to-day Pharmacovigilance activities in a highly regulated environment • Participate in on-call duties for specific projects to provide 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 • 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 • 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 experience providing relevant knowledge, skills, and abilities • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Thorough understanding of pathophysiology and disease processes • Strong knowledge of relevant therapeutic areas for processing adverse events • Excellent critical thinking and problem-solving skills, including appropriate evaluation and escalation • 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 compliance with procedural documents and regulations • 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 • Global team environment • Scientific excellence-focused workplace

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