Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP.
Responsible for leading and overseeing local pharmacovigilance activities, including adverse event case processing, safety reporting to Health Authorities, customer complaint handling, regulatory compliance, data quality, and stakeholder collaboration across clinical development and post-marketing activities.
Preferred certifications include pharmacovigilance or drug safety training from recognized industry bodies such as DIA or similar professional organizations.
Maintain safety tracking systems and ensure timely completion of assigned activities and deliverables. Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required.
Preferred knowledge of other related disciplines e.g. clinical, regulatory affairs, clinical statistics relevant to aggregate report writing and clinical development
Serve as the accountable business system owner for PV-related platforms, including safety databases, signal management tools, medical information systems, literature monitoring solutions, and reporting platforms