Experience

Belupo Pharmaceuticals & Cosmetics Inc.

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Head of Medical Affairs and Pharmacovigilance with role of EU QPPV

  • Jul 2013 - Present

• Head of Medical Affairs and Pharmacovigilance

  • Feb 2011 - Present

  As Head of Medical Affairs and Pharmacovigilance I am responsible for clinical and non-clinical documentation for marketing authorisations, for coordination of clinical and non-clinical trials in agreement with CRO-s. I am responsible for non-clinical and clinical development program for generic drugs. I am also qualified person for pharmacovigilance responsible for establishment and maintenance of the company pharmacovigilance system.

• Head of Medical Affairs

  • Jun 2006 - Mar 2011

  Clinical documentation for marketing authorisation applications for EU and non-EU markets, clinical development projects, medical opinions and proposals for portfolio management team.Establishing the pharmacovigilance system, pharmacovigilance documentation and activities. Qualified person for pharmacovigilance in Croatia.

• Head of Clilnical Documentation

  • Jun 2005 - Jun 2006


PLIVA
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Clinical expert in Regulatory Affairs

  • Jul 2003 - May 2005
• Regulatory Documentation Specialist

  • Jan 2001 - Jan 2003

• Regulatory Affairs

  • Aug 1995 - Dec 2000


PLIVA d.d
• Chemical Manufacturing
• 1 - 100 Employee
• Medical advisor

  • Jul 1994 - Jul 1995

Clinical Hospital Center Rebro
• Medical doctor

  • Jan 1990 - Jun 1994