
A professional background in clinical research (pharmacovigilance and transactional quality assurance) for more than 4 years of experience showing outstanding proficiency with the associated organizations. I have an agenda to secure a challenging position in an organization that offers professional growth while being value creator, flexible, resourceful and innovative contributing towards success of the organization. Detail-oriented Quality Control Analyst while Demonstrating knowledge of scientific principles. Strong background in collecting and analyzing quality measures and making recommendations for process and quality improvements.
Review and evaluate AE case information to determine required action based on and following internal policies and procedures
Answer any pharmacovigilance/drug safety related enquiries from external customers, such as Health care providers (HCP/Non-HCP) or patients
Quality reviewer for registered ICSR Collection, documentation, quality reviewer and following Up of all adverse events within area of responsibility from all sources including reports related to Pregnancy, breastfeeding, lack of efficacy, suspected transmission of infectious agents, overdose, abuse, misuse and medication errors
Database familiarity- ARISG, Argus, AE TrackerExperience and knowledge in E2B, CIOMS, MEDWATCH, EVWEB format electronic data remediation and data basing
To support creation, maintenance, review and implementation of the local/regional/global Pharmacovigilance related procedures
SME and expertise in ICD-10 codes (International Classification of Diseases) and nomenclature
Experience in Therapeutic Areas: Oncology, Dermatology, Respiratory, Immunology
Well versed with MS Office