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Safety Specialist
1 month ago
Transforming Drug Development
CSS Fortrea Scientific Pvt Ltd is seeking a highly motivated and detail-oriented Safety Specialist to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
Key Responsibilities:
- 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.
- Efficiency in conducting literature searches for authoring various types of reports.
- Author/review various safety reports (or part of such reports) for global regulatory submissions for our clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports, and other clinical documents as assigned.
- Perform/review Signal detection activities.
- Author/review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports.
- Perform allied activities like: Generation of line listings and summary tabulation, CFIs CFCs.
- Search literature databases for relevant information, recommend label changes, author proposed label text, and prepare supporting/justification document.
- Author/review SOPs/WIs/process documents or sections as applicable.
- Impart/conduct Trainings for peers and team members.
- Any additional activities as per the project requirement or manager's discretion on completion of relevant trainings.
About Us:
CSS Fortrea Scientific Pvt Ltd is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We offer a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
