Safety Writer

Process Implementation:

• Implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
• Ensure compliance of operations with governing regulatory requirements.
• Create, maintain, and assume accountability for a culture of high customer service.

Literature Search and Reporting:

• Conduct efficient literature searches for authoring various types of reports.
• Author/review various safety reports (or parts of such reports) for global regulatory submissions for Fortrea s clients.

These reports include:

• Annual Reports (IND and others)
• Periodic Safety Update Reports
• Periodic Adverse Drug Experience Reports
• Periodic Benefit-Risk Evaluation Reports
• Bridging Reports
• Other clinical documents as assigned.

Signal Detection and Risk Management:

• Perform/review signal detection activities.
• Author/review Risk Management Plans (RMP), ad hoc reports, Safety Update Reports, Benefit-Risk Evaluation, CCDS supporting documents, ACOs, and Addendum Reports.

Allied Activities:

• Generate line listings and summary tabulations.
• Perform CFIs and CFCs.
• Search literature databases for relevant information, recommend label changes, author proposed label text, and prepare supporting/justification documents.

SOPs and Training:

• Author/review SOPs, Work Instructions (WIs), process documents, or sections as applicable.
• Conduct training for peers and team members.

Additional Responsibilities:

• Perform any additional activities as per project requirements or manager s discretion upon completion of relevant training.

Knowledge and Skills:

• Strong understanding of regulatory requirements and safety reporting.
• Proficiency in literature search and data analysis.
• Excellent communication and writing skills.
• Ability to manage multiple tasks and deliver high-quality results under tight deadlines.
• Strong project management and organizational skills.

Experience:

• Relevant experience in a similar role within the pharmaceutical, biotechnology, or medical device industries.

Education:

• Bachelors degree in a related field (eg, Life Sciences, Pharmacy, Medicine) required