Drug Safety Associate (DSA) – Clinical Trial Cases

Job DescriptionDrug Safety Associate (DSA) – Clinical Trial Cases
Location: Hyderabad
Experience: 2–5 Years
Department: Pharmacovigilance / Drug Safety
Employment Type: Full-Time
Industry: Clinical Research / Life Sciences / Pharmacovigilance
About the Role
We are looking for a Drug Safety Associate (DSA) – Clinical Trial Cases to support the processing and management of Individual Case Safety Reports (ICSRs) arising from clinical trials.
The role will be responsible for accurate and timely case processing, data entry, medical coding, narrative writing, quality review, and follow-up activities in accordance with applicable SOPs, study-specific requirements, and global pharmacovigilance regulations.
Key Responsibilities
Process clinical trial safety cases/ICSRs received from clinical trials, investigators, sponsors, and other sources.
Perform case intake, triage, validity assessment, data entry, and case processing in the safety database.
Review source documents and ensure accurate capture of patient, event, suspect/concomitant medication, medical history, laboratory, and other relevant information.
Perform MedDRA coding for adverse events and medical conditions.
Perform WHO Drug / appropriate drug coding for medicinal products, where applicable.
Prepare clear, accurate, and medically coherent case narratives.
Assess cases for seriousness, expectedness, causality, and reportability as per study/client requirements and applicable procedures.
Identify and manage duplicate cases.
Conduct and document follow-up activities to obtain missing or clinically relevant information.
Ensure cases are processed within defined regulatory and client-specific timelines.
Support quality control/review of cases and address QC findings within agreed timelines.
Ensure compliance with applicable SOPs, work instructions, study protocols, safety management plans, and client requirements.
Maintain accurate case documentation and audit trails in accordance with quality requirements.
Participate in reconciliation activities with clinical databases and other relevant data sources.
Support preparation of case-related reports, metrics, and tracking reports.
Identify process issues, recurring errors, and potential safety signals and escalate them appropriately.
Support client meetings, audits, inspections, and other PV quality activities when required.
Required Qualifications
B.Pharm / M.Pharm / Pharm.D / Life Sciences or a relevant healthcare/science qualification.
2–5 years of relevant Pharmacovigilance experience, preferably in clinical trial safety case processing.
Hands-on experience in ICSR processing for clinical trial cases.
Good understanding of seriousness, causality, expectedness, and reportability assessment.
Knowledge of MedDRA coding and safety case processing principles.
Good understanding of ICH-GCP and ICH pharmacovigilance guidelines.
Working knowledge of global pharmacovigilance regulations and clinical trial safety reporting requirements.
Experience working with safety databases such as Argus, ArisG, Veeva Vault Safety, or similar systems will be an advantage.
Strong written and verbal communication skills.
Good attention to detail and ability to work within strict timelines.
Preferred Skills
Experience handling SAE/SUSAR and clinical trial ICSRs.
Experience with case narrative writing and follow-up query generation.
Exposure to clinical database reconciliation.
Experience working on global clinical trials and multinational client projects.
Ability to interpret clinical and medical information from source documents.
Strong analytical and problem-solving skills.
Ability to manage multiple priorities in a deadline-driven environment.
Key Competencies
Pharmacovigilance & Clinical Trial Safety
ICSR Case Processing
Medical Coding
Case Narrative Writing
Regulatory Compliance
Quality & Accuracy
Attention to Detail
Timely Case Processing
Client Communication
Team Collaboration
What You Will Do
Intake → Triage → Data Entry → Medical Coding → Case Assessment → Narrative → QC → Follow-up → Submission/Reporting

Work arrangement
No