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The World Leader In Serving Science
Safety Writer II
Location
Serbia
Posted
85 days ago
Salary
0
Seniority
Mid Level
Job Description
Safety Writer II
Thermo Fisher Scientific
• Conducts data review, authoring, quality review, and project manages a wide range of clinical trial and marketed product safety writing deliverables. • Uses multiple PPD and client systems. • Functions in a lead role, serving as the primary point of contact for assigned safety writing deliverables. • Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement. • Mentors less experienced staff. • Ensures that assigned safety writing and project management tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations. • Participates in departmental initiatives; Serves as a subject matter expert in designated area.
Job Requirements
- Bachelor’s or higher scientific degree.
- Excellent English – both written and verbal.
- Advanced knowledge of Microsoft Office package.
- Task based project management experience and experience with interacting directly with clients.
- Good understanding and knowledge of aggregate safety report writing guidelines, and clinical trial and post-marketing pharmacovigilance.
- Experience of authoring device aggregate safety reports or clinical evaluation reports is preferable, although not essential.
- Must have a minimum of 2 years’ experience in authoring two or more of the following report/document types for medicinal products : DSURs (Development Safety Update Reports) PBRERs / PSURs (Periodic Benefit Risk Evaluation Reports / Periodic Safety Update Reports) PA(D)ERs (Periodic Adverse [Drug] Experience Reports) RMPs (Risk Management Plans)
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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