Client Dedicated Safety Writer II

🔥 59 minutes ago

🌐 Serbia, Greece, +3 more countries – Remote

🇷🇸 Serbia – Remote 🇬🇷 Greece – Remote 🇵🇱 Poland – Remote 🇭🇺 Hungary – Remote 🇭🇷 Croatia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✏️ 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 multiple clinical trial and/or marketed product projects • Perform day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment • Conduct data review, authoring, and quality review for clinical trial and marketed product safety writing deliverables • Project manage low- to medium-complexity deliverables, including line listing reports, PA(D)ERs, DSURs, PSURs/PBRERs, and dRMPs • Support authoring of higher-complexity deliverables • Use multiple company and client systems and interact with project team members and clients • Serve as the primary point of contact for assigned safety writing deliverables • Ensure safety writing and project management tasks comply with company policies, procedures, contractual agreements, and applicable regulations • Review regulatory/pharmacovigilance publications and information sources • Lead kick-off meetings, manage communications and data requests, participate in client meetings, audits, and inspections, and review metrics and budgets • Collaborate with PVG and PPD project teams, client contacts, and third-party vendors

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience providing relevant knowledge, skills, and abilities • Combination of appropriate education, training and/or directly related experience may be considered sufficient • Comprehensive knowledge and experience of ICH and US aggregate safety reporting formats relating to clinical trials and/or marketed products • Thorough attention to detail; strong data interpretation and medical-scientific writing skills • Strong critical thinking and problem solving skills with ability to evaluate and escalate appropriately • Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision • Skilled at complex project administration including budget activities and forecasting • Strong oral and written English language communication skills, including paraphrasing skills • Solid computer skills and ability to work within multiple systems; proficiency in Microsoft Office products, including Outlook, Word, and Excel • In-depth understanding of global regulatory requirements pertaining to pharmacovigilance and compliance with procedural documents and regulations • Ability to maintain a positive and professional demeanor in challenging circumstances • Ability to work effectively within a team to attain a shared goal

🏖️ Benefits

• Collaboration and development opportunities • Global team environment • Scientific excellence-focused work environment

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