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.
Medical Director – M-SERM
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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
• Maintain understanding of methods for recording project and administrative time, submitting expenses, and handling travel. • Ensure delegated Pharmacovigilance tasks are properly executed and comply with applicable regulations, ICH guidelines, client directives, project WPDs, and CRG policies and SOPs/WPDs. • Provide medical consultation to team members and answer project- and study-related medical questions. • Communicate with associates and clients to ensure procedures are followed appropriately. • Provide safety reporting training on assigned projects and studies as requested. • Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources. • Review adverse events of special interest, serious adverse events, and clinical outcomes events reported in clinical trials. • Perform contract-defined data review and validation, including coding listings and full safety data, to identify potential safety concerns. • Assist with writing and/or reviewing CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related safety documentation. • Manage signal detection activities and scientifically review periodic safety reports. • Contribute to label updates, dossier maintenance, and risk management activities. • Mentor and train entry-level Pharmacovigilance staff and liaise with CRG groups and clients.
🎯 Requirements
• MD or equivalent required • At least one of the following: clinical experience with direct responsibility for diagnostic and treatment decisions comparable to 2 years, or direct experience in medical review and assessment of safety information/Pharmacovigilance comparable to 3 years • Fluent in spoken and written English • General medical knowledge of diagnostic and therapeutic approaches across multiple specialties • Working knowledge of FDA, ICH, EMA, and GCP guidelines • Understanding of basic biostatistics, data management, and clinical operations procedures • Working knowledge of the drug development process and guidelines for marketing authorization submissions and international clinical studies • Working knowledge of clinical program and study design, relevant endpoints, safety considerations, and the regulatory and commercial landscape • Working knowledge of marketed-product pharmacovigilance regulations • Working knowledge of Drug Safety Dictionaries such as MedDRA • Working knowledge of safety databases such as ARGUS and ARISg • Ability to mentor and train entry-level Pharmacovigilance staff • Flexibility to travel domestically and internationally • Proficiency in basic computer applications • Strong decision-making, problem-solving, organizational, analytical, communication, and interpersonal skills • History of an active medical license highly preferred
🏖️ Benefits
• Fully remote work arrangement • Flexibility to travel domestically and internationally • Reasonable accommodation for individuals with disabilities during the application, interview, and employment process
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