International Consultant @ Vet-Online Consultancy, Freelancer Drug Safety and Regulatory Affairs

International Consultant available for projects;
•    QPPV within EU available for (Veterinary) Pharmaceutical Companies. Physician on background available. Regulatory Affairs Contact. 

Pharmacovigilance (Veterinary) Medicines and Reconciliation;
•    Internal Audit or set up PharmacoVigilance System Veterinary Medicines; incl. Set PSMF and Written Procedures
•    AE reporting within EU both human and veterinary and US (FDA) veterinary; Data entry AE Reports into FDA database and Eudravigilance/ EV Web (also experience with ARISg Xchange (case registration), PV Works. Reconciliation cases (Outlook/ CIOMS- electronical route) 
•    PSUR writing (veterinary), harmonisation of PSUR´s/ Benefit Risk Assessments, contact person for marketing authorisation holder´s after Authority inspection etc. 
•    Reconciliation Agreements PharVig/ Distribution Agreements and contactperson to affiliates;
•    Reconciliation and comparing human and veterinary SPC´s with CCSI´s, CSP, PSUR-SAR etc. scientific article search to support application of Variations on SPC. 

Post marketing product management;
•    Set up and check of medical terminology and text on labelling/ leaflet/ SPC/ commercial art work and Drug Safety of the product. Set up Webinar.
Signal Detection / Annual Statements Iris

Regulatory Affairs (Veterinary) Medicines;
•    within the EU: regulation of Authorisations Veterinary Medicines, full management procedure, set up Initial Procedure (Generic products),  for generics BE study and Residue study set up clinical trials. MUMS clinical trial set up. 
•    NP/ MRP/ DCP/ MUMS/ incl. e-Submission  Veterinary, set up dossier in TIGes, VNEES / working with CESP and Eudralink/ IRIS/ UPD Variations/ set up SPC/ set up Mock Up´s, Labelling-Leaflets/ procedural contact marketing authorisation vs authorities etc.