Role & responsibilities
Conduct continuous surveillance and review of clinical trial data to ensure data integrity, accuracy, and patient safety.
Identify, track, and evaluate adverse events (AEs) and reliable adverse events (SAEs) in clinical safety databases.
Perform signal detection and trend analysis on safety data using specialized Pharmacovigilance (PV) and EDC (Electronic Data Capture) platforms.
Ensure accurate medical coding of clinical data using industry-standard dictionaries such as MedDRA and WHO-DD.
Collaborate closely with Clinical Data Management (CDM) teams to generate, track, and resolve data queries and discrepancies.
Ensure all data surveillance and reporting activities strictly comply with ICH-GCP guidelines and global regulatory standards.
Prepare and review safety data summaries, patient narratives,
and compliance reports for cross-functional teams.
Preferred candidate profile
Masters degree in Pharmacy (M.Pharm), Pharmacology, Biotechnology, or Life Sciences.
Robust foundational knowledge of pharmacovigilance, drug safety monitoring, and clinical data management (CDM).
Familiarity with EDC systems, medical terminology, and clinical trial processes.
Highly analytical mindset with exceptional attention to detail when reviewing large and complex medical datasets.
Robust communication and problem-solving skills to work effectively within cross-functional clinical teams.