- 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.