• 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.
• Conduct literature searches for authoring various types of reports efficiently.
• Author/review various safety reports for global regulatory submissions, including Annual Reports, 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 documents.
• Author/review SOPs/WIs/process documents or sections as applicable.
• Conduct training sessions for peers and team members.
• Perform any additional activities as per the project requirement or manager’s discretion upon completion of relevant training.

Qualifications:

• Motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
• Commitment to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

Application Link

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