Experience

DADA Consultancy B.V.

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Consultant Pharmacovigilance

  • Apr 2020 - Present

  Consultant serving multiple clients in their pharmacovigilance activities, global and local. Acting as EU-QPPV.



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Patient Safety Sr Specialist _ Local RMP manager _ deputy Country Head Patient Safety

  • May 2017 - Apr 2020

• Drug Safety Specialist _ Local RMP Manager

  • Oct 2014 - May 2017

• Drug Safety Manager

  • Nov 2013 - Oct 2014

  Arnhem Local RMP manager Support of Drug Safety department

• Medical Information Specialist

  • Apr 2013 - Oct 2013

  Arnhem Core business: provide answers to medical enquiries about the Novartis portfolio products coming from all different customers, a.o doctors, pharmacists, patients Support to Drug Safety department and medical advisers.

• Drug Safety Manager

  • Oct 2012 - Mar 2013

  Arnhem During 6 months I was responsible for management of Risk Management Plans (RMPs) within the company. This was a temporary assignment for replacement of a colleague during her maternity leave.



Disphar International BV

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmacovigilance Officer - Deputy EU-QPPV

  • Mar 2009 - Apr 2012

  Hengelo Gld - Baarn As Pharmacovigilance Officer, I am responsible for handling of all necessary aspects of pharmacovigilance and medical device vigilance for several companies involved. This means: • Acting as Deputy EU-Qualified Person for Pharmacovigilance for several companies in EU countries • Acting as Drug Safety Officer for the Dutch market • Organisation and faciliation of the Pharmacovigilance department according to current and upcoming legislation • Setup and maintenance of the quality… Show more As Pharmacovigilance Officer, I am responsible for handling of all necessary aspects of pharmacovigilance and medical device vigilance for several companies involved. This means: • Acting as Deputy EU-Qualified Person for Pharmacovigilance for several companies in EU countries • Acting as Drug Safety Officer for the Dutch market • Organisation and faciliation of the Pharmacovigilance department according to current and upcoming legislation • Setup and maintenance of the quality manual including SOPs, Detailed Description of PhV System • Training of PhV personnel within international organisation • Training of all local staff on PhV awareness. • Case management from AEs to periodic reports, from contacts with reporters from the market in the Netherlands to expedited reporting by EudraVigilance. • Support to Regulatory Affairs on PhV matters including compilation of responses to competent authorities, coordination of PSUR writing, Clinical Expert Statement, Renewal procedures. • Collaboration with R&D department on review of clinical trial documents as protocols, AEs, study reports. Responsible person for clinical safety reporting like SAEs. • Drafting and negotiation on Safety data exchange agreements and PhV Service agreements in collaboration with Legal affairs. • Case management concerning medical devices in collaboration with QA department • Support on Medical Information function to the Sales representatives. • Support on writing and implementation of Risk Management Plans including Risk Minimisation Actions • Coordinate and discuss outsourced tasks with the involved consultants. • All other safety related issues.

• Pharmacovigilance officer

  • Mar 2008 - Mar 2009

  Hengelo Gld. - Baarn



Organon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Safety Surveillance Coordinator

  • Feb 2005 - Mar 2008

  • Data entry and medical evaluation of safety reports from postmarketing and clinical trial (S)AE reports. • Assistant Medical safety advisor. • Writing Periodic Safety Update report, Clinical Trial report. • Clinical Trial safety coordination consisting of monitoring the safety profile of subjects particitipating in a clinical trial. • Experience with clinical trials on hormone therapy in menopause and assisted reproductive technology. • Contacts with Datamanagment, Regulatory… Show more • Data entry and medical evaluation of safety reports from postmarketing and clinical trial (S)AE reports. • Assistant Medical safety advisor. • Writing Periodic Safety Update report, Clinical Trial report. • Clinical Trial safety coordination consisting of monitoring the safety profile of subjects particitipating in a clinical trial. • Experience with clinical trials on hormone therapy in menopause and assisted reproductive technology. • Contacts with Datamanagment, Regulatory affairs, CRAs, study investigators and other physicians about (S)AE reports Show less



Radboud University

• Netherlands
• Research Services
• 700 & Above Employee

• Junior researcher Biochemistry

  • Jun 2000 - Jul 2004

  • Research topic: Biochemical properties of peptidylarginine deiminase and citrullinated proteins related to rheumatoid arthritis • Teaching theory and practical techniques of Biochemistry for 2nd year students.