Cedric Alexandre Binyam Binyam

Cardiology (post marketing product, injectable and oral formulation). Activities: conducting benefit risk evaluation; signal detection, validation and assessment; labelling update; authoring sections for responses to Health Authority requests; reports writing (PBRERs, RMP, PADER, Addendum to the clinical overview); contribution of pharmacovigilance update information intended for HCP; represent safety position in cross functional submission teams; mentor trainee for signals management.

Rhumatology and support activities in internal medicine 1- Medical review of ICSRs: ADR selection - MedDRA coding, analysis on causality (French and WHO-UMC causality assessment method), seriousness and expectedness - Medical assessment and define further needed follow-up information – Writing narratives and company comment. 2- Monthly quality control. 3- Training (in english) of pharmacovigilance officers from subsidiaries on PV regulation, coding conventions and safety evaluation rules.

1- Transversal activity between pharmacovigilance, regulatory affairs and quality assurance. 2- Implementation of standard reply and updating of medical information. 3- Identification of PV cases and management of regulatory affairs’ queries. 4- Monitoring of monthly queries, signal analysis, corrective actions for recurrent issues in the correspondent therapeutic area. 5- Boarding of experts

1- Processing of ICSRs. 2- Weekly review of literature. 3- Writing SOPs, PSURs and updating PSMF. 4- Reconciliation of PV and clinical trials databases. 5- Monitoring of reporting compliance to CA. 6- Medical information. 7- Monitoring of EU pharmacovigilance regulation.

1- Clinical trials implementation in accordance with Good Clinical Practices (GCP). 2- Submission of protocol amendments. 3- Screening of volunteers. 4- Medical follow-up visits. 5- Implementation of case report form. 6- Documentation and data entry of adverse events. 7- Monitoring and quality audits.

Eudravigilance training: “Electronic reporting of ICSRs in the EEA”

Pharmacovigilance training on specific items: case processing of specific targeted important medical event, exposure during pregnancy, lack of efficacy, overdose, abuse, off label use, misuse and medication error.

Clinical trials’ pharmacovigilance, pharmacoepidemiology, risk-benefit assessment, risk management plan and off label use.

Initial pharmacovigilance training

GCP, methodology of clinical trials, statistical methodology, ethical and regulatory issues, principles of pharmacovigilance, critical reading of scientific publications.