Safety Writer III

🔥 47 minutes ago

🌐 Greece, Serbia, +2 more countries – Remote

🇬🇷 Greece – Remote 🇷🇸 Serbia – Remote 🇧🇬 Bulgaria – Remote 🇭🇷 Croatia – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

✏️ Content Writer

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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

• 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