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 serious 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.
- Strong communication and problem-solving skills to work effectively within cross-functional clinical teams.