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:

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

Safety Writer