Senior Safety Specialist, FSP

🔥 5 minutes ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🟠 Senior

✨ Safety Specialist

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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 day-to-day pharmacovigilance activities • Participate in on-call duties for specific projects to ensure 24-hour case-intake coverage from investigative sites • 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 • Prepare and maintain regulatory safety reports • Assist with routine project implementation and coordination, including Clinical Trials and Endpoint Assessment Committee/Data Safety Monitoring Committee activities • Present at client and investigator meetings • Review metrics and budget considerations • Mentor less experienced staff • Collect, monitor, assess, evaluate, research, and track safety information • Perform data entry, coding, adverse-event assessment, case review, follow-up, report tracking, and regulatory reporting • Collaborate with project team members, client contacts, investigators, adverse-event reporters, and third-party vendors • Assist with departmental and project-specific procedures and processes • Prepare for and attend audits, kick-off meetings, and investigator meetings

🎯 Requirements

• Bachelor's degree in life science field • 2+ years of experience providing relevant knowledge, skills, and abilities • Equivalency may be considered through a combination of appropriate education, training and/or directly related experience • General understanding of pathophysiology and disease processes • Detailed knowledge of relevant therapeutic areas for adverse-event processing • Strong critical thinking and problem-solving skills • Good oral and written communication skills, including paraphrasing skills • Good command of English and ability to translate information into local language where required • Computer literacy and ability to work within multiple databases • Previous exposure to Microsoft Office packages, including Outlook, Word, and Excel • Understanding of 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

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Opportunity to contribute to patient safety and scientific excellence

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