Safety Specialist II
hace 2 semanas
About the Role
We are seeking a highly skilled Safety Specialist II to join our team at Thermo Fisher Scientific. As a key member of our safety team, you will be responsible for managing the safety profile of new drugs in clinical trials, overseeing case-processing activities, and performing regulatory reporting and medical monitoring tasks.
Key Responsibilities
- Plan, coordinate, and deliver signal detection and product safety scientist activities
- Support mentoring of junior colleagues and development of processes, tools, and systems
- Lead small FSP projects and participate in bid defense and proposal development activities
- Work within multiple company and client systems, interacting with project team members and clients
- Ensure tasks are conducted in accordance with company policies and procedures, contractual agreements, and applicable regulations
Requirements
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification
- Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 8+ years)
- Expertise in pharmacovigilance requirements relating to marketed products and clinical trials across all major markets
- Excellent attention to detail, data interpretation, and medical-scientific writing skills
- Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately
- Ability to motivate, mentor, and provide guidance to less experienced staff
What We Offer
At Thermo Fisher Scientific, we offer a dynamic and supportive work environment, continued career advancement opportunities, award-winning training, and benefits focused on the health and wellbeing of our employees.
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