Responsibilities:
- Confirm the validity of cases by identifying minimum criteria for case creation.
- Perform duplicate searches to create either an initial case or a follow-up case.
- Understand the principles and concepts associated with patient safety case-handling processes, including regulatory requirements for reporting individual case safety reports.
- Identify serious adverse events and special scenario cases, including lack of efficacy, exposure, pregnancy cases, at-risk cases, and product quality complaint only cases.
- Attach relevant source documents or any safety information/queries/follow-up information relevant to the case.
- Facilitate follow-up based on queries from Data entry/QC/MR or based on inconsistent/missing information in the source file.
- Code adverse events, medical history, lab data, indications, etc., using standardized terminology from a medical coding dictionary, such as MedDRA.
- Code products (suspect/co-suspect, concomitant) as per client conventions and regulatory requirements.
- Draft narratives.
Qualifications:
- Understanding of principles and concepts associated with the case-handling process and overall drug research process.
- Cognitive abilities, including verbal reasoning, attention to detail, and critical and analytical thinking.
- Good knowledge of therapy areas and medical terminology.
- Good comprehension skills.
- Good communication skills (verbal and written) with fluency in English and interpersonal skills.
- Immediate joiners only.
