Drug Safety Associate

3 days ago

Bengaluru Karnataka, India Indegene Full time

**Date**:20 Sept 2025

**Location**:Bangalore, KA, IN
- Job Description-
- Must Have- Data Management:

- Perform duplicate search as per the requirement.
- Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, and in accordance with client specific requirements and timelines.
- Identify serious adverse events, and special scenario cases which includes lack of efficacy, exposure and pregnancy case, At Risk, and product quality complaint only cases.
- Ensure scientific rigor through accurate, complete and consistent data entry of adverse events reports from source document with emphasis on timeliness and quality.
- Data entry of all fields including verbatim as per Client conventions.
- Responsible for coding which includes 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 summarizing the essential details of the case.
- Identify clinically relevant information missing from case report and facilities its collection
- Perform labeling for Serious/Non-Serious Cases
- Request for follow-up information by using relevant questionnaire
- Follow standard operating procedures (SOPs) and work instructions related to case processing. Adhere to pharmacovigilance regulations, guidelines, and internal policies to ensure compliance and data integrity. Understanding adverse event reporting requirements and compliance with data privacy regulations is important.
- Should be open to continuous learning, staying updated with industry changes, new reporting requirements, and emerging safety concerns.
- Skills:

- Understand the principles and concepts associated with case-handling process and overall Drug Research Process.
- Handling of cases in ArisG LSMV safety database.
- Cognitive abilities including verbal reasoning, attention to detail, and critical and analytical thinking
- Good knowledge on therapy area/medical terminology
- Good comprehension skills
- Good communication (verbal and written), with fluency in English and interpersonal skills

Your impact:
About you: (Desired profile)
Must have:

- Attention to detail
- Good comprehension skills.
- Good communication (verbal and written), with fluency in English and interpersonal skills.
- Good to have- EQUAL OPPORTUNITY

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