Senior/Principal Drug Safety Specialist

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🕒 3 days ago

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

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

•Works independently to perform day-to-day PV activities. •May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. •Operates in a lead capacity. •Provides assistance in the development of program and departmental procedural documents. •May prepare for and attend audits. •Mentors less experienced staff. •Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. •Maintains medical understanding of applicable therapeutic area and disease states. •Reviews cases entered for quality, consistency and accuracy, including review of peer reports. •Responsible for routine project implementation and coordination (e.g., Clinical Trials and Post Approval, including presentations at client meetings, and review of metrics and budget considerations.

🎯 Requirements

•Bachelor's degree or equivalent and relevant formal academic / vocational qualification •Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). •Thorough understanding of pathophysiology and the disease process •Strong knowledge of relevant therapeutic areas as required for processing AEs •Proficient at complex clinical study administration including budget activities and forecasting •Good command of English and ability to translate information into local language where required •Computer literate with the ability to work within multiple databases •Proficient in Microsoft Office products (including Outlook, Word, and Excel) •Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations •Ability to manage and prioritize a variety of 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 to attain a shared goal.

🏖️ Benefits

•Professional development opportunities •Global team events