Work experience

• Argus Database functional Administrator

  Enovalife

  2024.04-Current

  (2 years)

  ❖ Management of Argus administration: studies, products/licenses configuration ❖ Edition of listings in Business Object/ Listings configuration in Argus ❖ Ticket management (gechap) ❖ Management of datasheets in the corresponding medDRA version ❖ Submission of SUSARs (blinded or unblinded) to CA, partners and affiliates ❖ Monitoring of Bulk ICSR including management of negative Ack, Xml generation failure and resubmission to CA/partners if applicable ❖ Update/creation of reporting rules following new regulatory requirements, or PVA/SDEA creation or update ❖ Technical support for operational team (case processing vendor)
• Pharmacovigilance System Officer

  Stragen Services SAS

  2023.05-2024.04

  (a year)

  ❖ Management of Safety Easy administration: users creation and access management, product/studies creation and update, ticket management ❖ Safety Easy 25 release: Script of test redaction and testing of the new mantis ❖ Eudravigilance testing in XCOMP environment ❖ Eudravigilance: Registration of organizations, users access, XEVPMD data entry, ICSRs download ❖ Regulatory monitoring regarding post-marketing and clinical trials activities ❖ Management of users pharmacovigilance trainings
• Argus Database functional Administrator

  Business&Decision Life Sciences

  2020.10-2023.05

  (3 years)

  ❖ Management of Argus administration: studies, products/licenses configuration ❖ Edition of listings in Business Object/ Listings configuration in Argus ❖ Incidents opening to the IT team via gechap interface ❖ Configuration of new Local Affiliate modules (LAM) ❖ Management of medDRA upgrade (25.1 to 26.0): communication with IT teams in order to respect the MedDRA loading due dates, make sure that the loading and recoding went well in Argus, test folder execution, communication to users ❖ Study unblind ❖ Quality control of migrated ICSR
• Drug Safety Associate

  Business&Decision Life Sciences

  2020.10-2021.07

  (10 months)

  ❖ Case processing of post-marketing ICSR in Argus database: narrative and company comment writing, medDra coding, scoring and AE assessment, listedness according to the SmPc, follow-up of action items, verification of the regulatory reports for submission
• Pharmacovigilance Datamanager

  Hays Pharma

  2016.12-2019.09

  (3 years)

  ❖ Case processing of post-marketing ICSR in Argus database: narrative writing, medDRA coding, adverse events assessment, scoring, ❖ ICSRs collection and acceptation (mailbox, Argus including E2b portal) ❖ Training of new employees ❖ Team leader back up (mailbox management)

Educational experience

• Paris Descartes university

  Cellular Biology physiology and pathology,

  2013.09-2015.06

  (2 years)

  Master specialized in neurosciences
• Paris Sud university

  Biology

  2011.09-2013.06

  (2 years)

  Licence specialized in biology

Languages