The Safety Writer is responsible for planning, coordinating, and delivering safety writing services for multiple clinical trial and/or marketed product projects within a regulated pharmacovigilance environment, adhering to strict timelines. This role involves project management, data review, authoring, and quality review of safety writing deliverables, including line listing reports, Periodic Adverse [Drug] Experience Reports (PA[D]ERs), and potentially more complex reports like Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs).
Essential Functions:
- Conduct data review, authoring, and quality review tasks on low complexity safety writing deliverables.
- Support authoring of medium complexity deliverables under supervision.
- 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 compliance with company policies, procedures, contractual agreements, and regulations.
- Stay updated on current regulations, practices, and procedures through review of regulatory/pharmacovigilance publications and information sources.
- Manage communications and data requests, and participate in kick-off meetings, client meetings, audits, and inspections.
Education and Experience:
- Bachelor’s degree or equivalent formal academic/vocational qualification.
- Previous experience (comparable to 2+ years) providing the knowledge, skills, and abilities required for the job.
- In some cases, a combination of education, training, and/or directly related experience will be considered sufficient.
Knowledge, Skills, and Abilities:
- Good knowledge of ICH and US aggregate safety reporting formats for clinical trials and/or marketed products.
- Attention to detail, data interpretation, and medical-scientific writing skills.
- Critical thinking and problem-solving skills with ability to escalate issues appropriately.
- Ability to manage and prioritize tasks and meet strict deadlines with modest supervision.
- Effective oral and written English communication skills, including paraphrasing skills.
- Proficient in using Microsoft Office products (Outlook, Word, Excel) and ability to work within multiple systems.
- Understanding of global regulatory requirements for 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 achieve shared goals.
Benefits: Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. We provide an innovative, forward-thinking work environment with outstanding career and development prospects.
