Safety Specialist
2 semanas atrás
**Job Summary**
Thermo Fisher Scientific is seeking a highly skilled Pharmacovigilance Specialist to join our team. As a key member of our Pharmacovigilance team, you will be responsible for performing day-to-day Pharmacovigilance activities within a highly regulated environment.
**Key Responsibilities**
- Collection, monitoring, assessment, evaluation, research, and tracking of safety information
- Coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities
- Collaboration with project team members, client contacts, investigators, and adverse event/reporters, and third-party vendors
- Preparation of departmental and project-specific procedures and processes, preparation for and attendance at audits, kick-off, and investigator meetings
**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 2+ years)
- General understanding of pathophysiology and the disease process
- Detailed knowledge of relevant therapeutic areas as required for processing AEs
- Strong critical thinking and problem-solving skills
- Good oral and written communication skills, including paraphrasing skills
- Computer literate with the ability to work within multiple databases
- Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
- Understanding 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
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