
Aspiring Pharmacovigilance professional with a strong academic foundation in Pharmacy and a keen interest in Drug safety and regulatory compliance. Seeking to leverage my knowledge and training to contribute to the success of a leading organization in the healthcare industry.
Quality management systems
Aggregate Reporting and timelines
Hands on training of Clinevo safety database
Basic Pharmacovigilance compliance
Basic Causality Assessment
MedDRA Coding in Clinevo safety database
Scientific literature review
ICSR Case processing and Signal detection and management
Adverse event reporting
Narrative writing
Regulatory Guidelines (ICH E2A to E2F) knowledge
USFDA, EMA (GVP Guidelines) and Indian Guidelines knowledge