Safety Writer III
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Job Description
Safety Writer III delivering clinical-trial and marketed-product pharmacovigilance reports for Thermo Fisher Scientific. Managing regulated safety writing projects, reviews, clients, and vendors.
Responsibilities:
- Plan, coordinate, and deliver safety writing services for clinical trial and marketed product projects
- Conduct data review, authoring, quality review, and senior review of safety writing deliverables
- Project manage low-, moderate-, and high-complexity safety writing deliverables
- Provide ad-hoc support for scientific safety services
- Use multiple PPD and client systems
- Collaborate with PVG, PPD/Evidera, client, and third-party vendor teams
- Serve as the primary contact for assigned safety writing deliverables
- Troubleshoot and resolve project issues and identify improvement areas
- Mentor less experienced staff
- Ensure work complies with company policies, contracts, regulations, and procedures
- Review regulatory and pharmacovigilance publications
- Participate in departmental initiatives and serve as a subject matter expert
- Lead kick-off meetings, manage communications and data requests, participate in client meetings, audits, and inspections
- Review project metrics and budgets
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 8+ years of previous experience, or comparable knowledge, skills, and abilities
- Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
- Highly skilled in ICH and US aggregate safety reporting formats for clinical trials and marketed products
- Knowledge of risk management plans
- Excellent attention to detail, data interpretation, and medical-scientific writing skills
- Advanced critical thinking and problem-solving skills
- Project management skills and ability to manage multiple projects simultaneously
- Ability to motivate, mentor, and guide less experienced staff
- Complex project administration skills, including budget activities and forecasting
- Excellent oral and written English communication skills, including paraphrasing
- Advanced computer skills and proficiency in multiple systems
- Advanced Microsoft Office skills, including Outlook, Word, and Excel
- Advanced understanding of global pharmacovigilance regulatory requirements
- Ability to comply with procedural documents, regulations, company policies, and contractual agreements
- Ability to work effectively within a team
- Occasional domestic and/or international travel required
Benefits:
- Fully remote work arrangement
- Standard office hours (40 hours per week)
- Professional development and collaboration opportunities
- Mentoring and guidance opportunities
- Global team environment
- Occasional domestic and international travel
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