André Reis De Carvalho Email & Phone Number

State Of São Paulo, Brazil

São Paulo, Brazil

Barueri

São Paulo, São Paulo, Brasil

As Global Pharmacovigilance (PV) Case Processing Leader at Bayer, I lead a group of physicians and other health care providers in data entry and medical evaluation of adverse events (AEs) from investigational and post-marketing products within the Therapeutic Area (TA) Oncology. This includes team management to achieve agreed-upon productivity levels, continuous improvement of processes to drive quality and efficiency, resource planning and workload management within the TA across the globe. I am also responsible for ensuring that the PV data entry and medical evaluation staffs provide efficient, timely case processing of high quality in Argus, in compliance with an evolving regulatory and scientific environment, as well as the Company's Standard Operating Procedures. Major Tasks of Role: • Supervise case processing and medical evaluation of all types of AE reports. • Liaise with Global Case Processing TA Head and the TA's Case Processing Leaders for short and long-term resource planning, as well as balancing workload across the other TAs in the Company. • Oversee the group's interactions with CROs and external vendors. • Liaise with the Case Processing Standards Leader and Global Case Processing TA Head in developing and adapting standards for ICSR processing and evaluation, providing input into global Quality Documents and GPV process-specific documents, as well as ensuring the group's adherence to global case processing and evaluation standards. • Ensure the correct medical coding of AE/SAE and drug terms, which requires in-depth knowledge of MedDRA, WHO-DD and Argus. • Analyze and provide regular feedback on QC findings to individual staff members and define the evolving training needs for TA personnel. • Liaise with the PV Benefit-Risk Management and support the definition of product specific needs for AE/SAE case evaluation (within the confines of global AE case consistency and standards). • Deputize for upper line manager as needed.

São Paulo, São Paulo, Brasil

As a Global Pharmacovigilance Expert Case Evaluator, I have the responsibility of performing medical evaluation and assessment of causality for adverse event/adverse drug reaction (AE/ADR) reports. Medical quality, consistency with company standards and medical science, and timely evaluation of case reports must be ensured in order to keep compliance with very strict international ADR reporting requirements and timelines. Expedited reporting of single case ADR reports to regulatory authorities largely depends on an accurate medical and causality assessment of cases. To achieve this, high levels of medical acumen as well as understanding of PV processes and requirements are absolutely necessary. The task is also important as it lays the foundation for information collection used in signal detection and evaluation of ongoing risk benefit assessments, as well as the compilation of periodic aggregate reports of the Bayer drugs. Major Tasks of Role:• Ensure medical plausibility, consistency and completeness of ADR case reports. • Determine the AE's seriousness and assess drug/product causal association and expectedness.• Oversee the medical coding of all AE and Drug terms. This requires in depth knowledge of MedDRA, WHO-DD and Argus.• Create written company causality comments for ADR case reports in accordance with internal standards and guidelines.• Diligent evaluation and assessment of complex reports from clinical development projects including specific aggregate analyses and summary description of previous similar reports when required.• Identify critical case reports that require immediate attention of the Global Safety Leader and pre-select cases that are potentially suitable for extended discussion in PV aggregate reports (PSURs and ASRs).• Serve as mentor for PV Case Processors and new PV Case Evaluators.• Participate in the analysis of AE/ADR reporting compliance reports.• Deputize for the Case Processing Leader as needed.

São Paulo E Região, Brasil

Médico da equipe de Ginecologia & Obstetrícia

Guarulhos

Guarulhos

Master Of Business Administration - Mba, Health Services Administration

MBA Executivo Insper-Einstein em Gestão de Serviços de Saúde

Residência Médica, Obstetrics And Gynecology Residency Program

Medicina