Responsible of the management of Pharmacovigilance, Medical Device Vigilance and Medical Information for Nordic Pharma in France.

Therapeutic area: rheumatology, gynecology and oncology - Receipt, management and validation of ICSR from EEA and non-EEA in a Safety Database- Management of medical information: update of FAQ and reply of phone calls- Preparation, redaction and validation of PSUR- Weekly scientific literature review for signal detection, ICSR and PSUR- Audit and Inspection (ANSM) participation- Redaction of Health Authorities answers upon request-… Show more Therapeutic area: rheumatology, gynecology and oncology - Receipt, management and validation of ICSR from EEA and non-EEA in a Safety Database- Management of medical information: update of FAQ and reply of phone calls- Preparation, redaction and validation of PSUR- Weekly scientific literature review for signal detection, ICSR and PSUR- Audit and Inspection (ANSM) participation- Redaction of Health Authorities answers upon request- Eudravigilance and EVDAS user- Update of RMP- Set up and follow up of TRU and pharmacovigilance survey Show less

Professional break after the 5th year of Pharmacy:-Intership in Regulatory affairs at Ferring Pharmaceuticals, Switzerland (2 months)-English lessons at the Horner school, Irlande (2 months)-Intership in Pharmacovigilance at Onxeo, France (6 months)-Fixed-term contract in Pharmacovigilance at Onxeo, France (1 month)-Student Exchange Program in ITB, Indonesia (2 months)

Teaching and correction of their evaluations

In charge of preparation and writing of Periodic Safety Report in compliance with regulatory requirements for submission to Health Authorities.

Preparation, support and follow up of audits and inspections at affiliates and global level.- One (1) intern audit / Three (3) extern audits- Three (3) affiliate inspections / One (1) global inspection conducted by EMA (ANSM and MHRA)

-Subject: Management of pharmacovigilance cases (post-marketing and clinical trial) and their validation (pertinent data and regulatory delays)

-Subject : Follows up variation submissions and changes with regulatory impact in frequent contact with Global Regulatory Affairs DepartmentRespond to health authority questions

-Sterile Medical Devices department/Medical Device Vigilance: Medical Devices management thoughout the operation rooms (urology and gastroenterology). -Infectious diseases service: In collaboration with the Health Professional, I made pharmaceutical interview, manage drugs and report the adverse drug reactions from hospitalised patients to Pharmacovigilance. Moreover I participate in the drafting and monitoring of a national clinical trial on pulmonary hypertention.

Creation of an intern quality control about embryo morphology, registered on an informatical data base

Reception, ordering, providing information on drugs, reviewing medication interactions ...