Role & responsibilities :
Review clinical-trial records, patient notes, lab reports, medication details, and source documents for adverse events or safety-related information.
Identify adverse events, serious adverse events, adverse drug reactions, medication errors, overdose, pregnancy exposure, and product complaints where applicable.
Enter safety-related information accurately into internal systems or safety databases.
Assist in initial case intake, triage, duplicate check, and case documentation.
Support preparation of Individual Case Safety Reports under supervision.
Check case details for completeness, medical accuracy, and consistency.
Follow up for missing safety information when required.
Assist in coding adverse events and medications if trained on MedDRA/WHO Drug dictionaries.
Escalate reliable, unexpected, or medically key events to senior reviewers.
Maintain timelines for safety case processing and documentation.
Follow pharmacovigilance SOPs, regulatory requirements, GCP, and data privacy standards.




Support AI-assisted safety detection workflows by validating flagged safety signals and documentation outputs.

Preferred candidate profile :
Basic knowledge of pharmacology, drugs, adverse drug reactions, and clinical terminology.
Ability to understand prescriptions, medication history, lab reports, clinical notes, and patient narratives.
Robust attention to detail.
Good written English and medical documentation skills.
Ability to identify safety-related information from clinical documents.
Basic understanding of pharmacovigilance concepts is preferred.
Ability to work with structured checklists, timelines, and quality standards.
Basic computer skills are mandator
Candidates with pharmacovigilance, clinical research, medical review, clinical data management, or healthcare documentation experience will be preferred.

📌 Pharmacovigilance Associate Telangana
🏢 TrialBridge India
📍 Telangana