Ana Goncalves
About Ana Goncalves
Ana Goncalves is the Pharmacovigilance and Medical Information Associate Director at Bristol-Myers Squibb in São Paulo, Brazil, with extensive experience in pharmacovigilance, regulatory affairs, and patient safety.
Current Role at Bristol-Myers Squibb
Ana Goncalves serves as the Pharmacovigilance and Medical Information Associate Director at Bristol-Myers Squibb, based in the São Paulo Area, Brazil. In her role, she ensures audit readiness and leads cross-functional teams to guarantee effective internal and external inspections. She acts as a point of contact for local health authorities regarding Pharmacovigilance (PV) issues and manages requests related to PV from these authorities. Her responsibilities include implementing Risk Management Plan Activities and writing specific country annexes for Brazil.
Former Roles at Bristol-Myers Squibb
Ana Goncalves has an extensive history with Bristol-Myers Squibb. From 2003 to 2011, she worked as a Pharmacovigilance Manager, overseeing safety-related matters within a matrix environment. Prior to this, she served as a Regulatory Affairs Analyst from 2002 to 2003. During her tenure, she was responsible for risk evaluation, mitigation strategies, and compliance with FDA regulations. She has also been involved in the development and implementation of REMS programs, including those with Elements to Assure Safe Use (ETASU).
Experience at Hospital das Clínicas - CEATOX
Before her extensive career at Bristol-Myers Squibb, Ana Goncalves worked as a Pharmacovigilance Assistant at Hospital das Clínicas- CEATOX from 1999 to 2001. In this role, she gained valuable experience in pharmacovigilance, contributing to the safe use and monitoring of medications.
Education and Academic Background
Ana Goncalves holds a Master's degree in Pharmacovigilance and Pharmacoepidemiology from Université de Bordeaux - EU2P, where she studied from 2019 to 2021. She also earned an MBA focused on the Pharmaceutical Industry from Fundação Getulio Vargas, completed between 2005 and 2007. Additionally, she studied at Pós Graduação - Faculdades Oswaldo Cruz from 1997 to 2001.
Commitment to Patient Safety and Public Health
Ana Goncalves has a strong commitment to patient safety and public health. She has extensive experience managing Risk Evaluation and Mitigation Strategies (REMS) programs and has been involved in patient education and communication outreach programs. Her work includes the safe distribution of medications such as Thalomid, Revlimid, and Pomalyst. She also provides pharmacovigilance training sessions aimed at local employees to ensure the safe use of medications and compliance with health regulations.