Andrea Bitu
About Andrea Bitu
Andrea Bitu is a Senior Specialist in Patient Safety at Bristol Myers Squibb in São Paulo, Brazil, with extensive experience in pharmacovigilance and customer service in the pharmaceutical industry.
Current Position at Bristol Myers Squibb
Andrea Bitu is currently serving as a Senior Specialist in Patient Safety for Bristol Myers Squibb in São Paulo, Brasil. She follows up on serious cases and pregnancies, and conducts quality reviews of reports. Her role involves ensuring the safety and well-being of patients by rigorously analyzing and managing adverse event reports.
Previous Roles in Pharmacovigilance
Andrea Bitu has extensive experience in the field of pharmacovigilance. She previously worked as a Senior Pharmacovigilance Analyst at Bristol Myers Squibb from 2019 to 2022 in São Paulo e Região, Brasil. Before that, she held similar positions at Hypermarcas S/A - Brainfarma S/A from 2017 to 2019 in Barueri, São Paulo, and at Aché Laboratórios from 2010 to 2017. Her career also includes a role as a Customer Relationship Analyst at Aché Laboratórios from 2006 to 2010.
Educational Background in Pharmacy
Andrea Bitu pursued her higher education in pharmacy, completing her graduation from Universidade São Judas Tadeu in 2009. She further specialized in Hospital Pharmacy, achieving a postgraduate degree from Faculdades Oswaldo Cruz between 2011 and 2013. Her educational background laid a strong foundation for her roles in patient safety and pharmacovigilance.
Skills and Responsibilities in Pharmacovigilance
Andrea Bitu has a robust skill set in pharmacovigilance, including the preparation of Pharmacovigilance Periodic Safety Update Reports (PSUR), notifying regulatory bodies like CVS, and developing Standard Operating Procedures (SOPs). She handles the capture, collection, and processing of reports, and performs causality assessments using methodologies such as Naranjo, Kart Lasagna, and WHO. She also monitors deviations and completes Corrective and Preventive Actions (CAPA).
Experience in Customer Service and Training
Apart from her technical expertise, Andrea Bitu has a significant background in customer service, specifically focusing on pharmaceutical care. She provides training for the Consumer Service Center and new employees, covering pharmacovigilance processes. Additionally, she engages in Technovigilance and Cosmetovigilance activities and collaborates closely with Quality Assurance and Regulatory Affairs departments.