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 serious, 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.
- Solid 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) (Hyderabad)
🏢 TrialBridge India
📍 Hyderabad