Experience

Ciclum Stada Portugal

• Regulatory Affairs &Pharmacovigilance

  • Aug 2008 - Present

• Pharmacovigilance Local Contact

  • Jun 2020 - Present

  - Elaboration/ Review of Pharmacovigilance Procedures.- Implementation of safety variations and urgent safety restrictions. - Elaboration, distribuition and submission of PSURS.- Local screening of Medical Literature

• Regulatory Affairs

  • Aug 2008 - Present

  - Marketing Authorisation life-cycle management and regulatory submissions (all type of procedures).- Contacts with national authorities, licensing and licensed companies, manufacturers and headquarters- Support on dossiers quality matters: assure manufacturing compliance according to dossier requirements- Registration and life-cycle management of medical devices, food supplements and cosmetics-Technical translations of SmPCs, PILs and packaging materials.- Revision of product artworks and promotional materials.- Local responsible for loading and checking Company database - Register® with all local products- Regulatory and technical support to users and health professionals (pharmacies and hospitals) concerning all company products- Ensure compliance (GDP, GMP) with appropriate quality SPO`s- Management of complaints, returns, counterfeits and market recalls



INFARMED

• Portugal
• Government Administration
• 200 - 300 Employee

• Project manager of renewal procedures

  • Oct 2007 - Jul 2008