Basel, Basel, Switzerland
- Global Regulatory Information Management Process Excellence Health Authorities requirements identification, interpretation and implementation (IDMP, Pharmacovigilance) Inspections preparation and SME (PBRERs, Regulatory Commitments) Inspections and audits findings impact assessment and CAPAs management Processes design and enhancement enabling compliance improvement Documentation development, training and change management Metrics definition and interpretation, dashboards design - Lead of medium to high-complex cross-functional global projects Coordination of strategic initiatives impacting regulatory processes and systems in a global matrix environment - Business process owner for Regulatory Commitments and Regulatory Information Tracker SOPs/guidelines development and implementation HQ/affiliates training and support Compliance definition and monitoring Business lead in regulatory systems change control boards
- Project management License & Market Cessation, Roche Biosimilars and Combo-packs, Decentralized Data Entry - Global Regulatory process development and systems enhancement Pharmacovigilance requirements, Compliance improvements - Key contact point for Regulatory HQ/affiliates and vendors Support Information Management requests and ensure quality of deliverables
- Business strategies development for Switzerland and Austria - Developed sales aids, product brochures, and trained sales forces - Created Bausch+Lomb Swiss website, french and german versions - Managed congresses organisation
- 3 months in Endocrinology department : Monitored diabetic patients, involved in treatment decisions with physicians - 3 months in Pharmacovigilance department : Analysis and synthesis of PSURs, clinical observations
- Developed innovative detection methods, improved a preclinical model - Studied respiratory toxics for my PharmD thesis