Client Dedicated Safety Writer II

This is a fully remote position, open to applicants in Serbia, +4 more countries.

📋 Description

• Plan, coordinate, and deliver safety writing services for various clinical trial and/or marketed product projects.

• Execute daily safety writing and related tasks within a highly regulated pharmacovigilance setting.

• Conduct data review, author, and ensure quality review for safety writing deliverables related to clinical trials and marketed products.

• Manage projects with low to medium complexity, including line listing reports, PA(D)ERs, DSURs, PSURs/PBRERs, and dRMPs.

• Assist in the authoring of more complex deliverables.

• Utilize multiple company and client systems while collaborating with project team members and clients.

• Act as the primary contact for assigned safety writing deliverables.

• Ensure that safety writing and project management responsibilities align with company policies, procedures, contractual obligations, and relevant regulations.

• Review regulatory and pharmacovigilance publications and other information sources.

• Lead kick-off meetings, manage communications and data requests, partake in client meetings, audits, and inspections, and assess metrics and budgets.

• Collaborate with PVG and PPD project teams, client representatives, and third-party vendors.

⛳️ Requirements

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.

• Over 5 years of prior experience providing pertinent knowledge, skills, and abilities.

• A combination of suitable education, training, and/or directly related experience may also be considered adequate.

• Extensive knowledge and experience of ICH and US aggregate safety reporting formats related to clinical trials and/or marketed products.

• Exceptional attention to detail; strong skills in data interpretation and medical-scientific writing.

• Strong critical thinking and problem-solving abilities, with the capacity to evaluate and escalate issues appropriately.

• Capable of managing and prioritizing various tasks while meeting tight deadlines with minimal supervision.

• Proficient in complex project administration, including budgeting activities and forecasting.

• Excellent oral and written communication skills in English, including the ability to paraphrase effectively.

• Solid computer capabilities and the ability to navigate multiple systems; proficiency in Microsoft Office applications, including Outlook, Word, and Excel.

• Comprehensive understanding of global regulatory requirements related to pharmacovigilance and compliance with procedural documents and regulations.

• Ability to maintain a positive and professional demeanor in challenging situations.

• Effectively work within a team to achieve common goals.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• A global team environment.

• A work environment focused on scientific excellence.