01 Aug
|
TrialBridge India
|
Hyderabad
01 Aug
TrialBridge India
Hyderabad
Role u0026 responsibilities :nn- Review clinical-trial records, patient notes, lab reports, medication details, and source documents for adverse events or safety-related information.n- Identify adverse events, serious adverse events, adverse drug reactions, medication errors, overdose, pregnancy exposure, and product complaints where applicable.n- Enter safety-related information accurately into internal systems or safety databases.n- Assist in initial case intake, triage, duplicate check, and case documentation.n- Support preparation of Individual Case Safety Reports under supervision.n- Check case details for completeness, medical accuracy, and consistency.n- Follow up for missing safety information when required.n- Assist in coding adverse events and medications if trained on MedDRA/WHO Drug dictionaries.n- Escalate serious, unexpected, or medically key events to senior reviewers.n- Maintain timelines for safety case processing and documentation.n- Follow pharmacovigilance SOPs, regulatory requirements, GCP,
and data privacy standards.n- Support AI-assisted safety detection workflows by validating flagged safety signals and documentation outputs.nnPreferred candidate profile :nn- Basic knowledge of pharmacology, drugs, adverse drug reactions, and clinical terminology.n- Ability to understand prescriptions, medication history, lab reports, clinical notes, and patient narratives.n- Strong attention to detail.n- Positive written English and medical documentation skills.n- Ability to identify safety-related information from clinical documents.n- Basic understanding of pharmacovigilance concepts is preferred.n- Ability to work with structured checklists, timelines, and quality standards.n- Basic computer skills are mandatorn- Candidates with pharmacovigilance, clinical research, medical review, clinical data management, or healthcare documentation experience will be preferred. .
📌 Pharmacovigilance Associate (Telangana) (Hyderabad)
🏢 TrialBridge India
📍 Hyderabad