Profileimage by Anonymous profile, International Consultant @ Vet-Online Consultancy, Freelancer Drug Safety and Regulatory Affairs
not available until 10/31/2024

Last update: 14.11.2023

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

Company: Vet-Online Consultancy
Graduation: MSc. VMD
Hourly-/Daily rates: show
Languages: German (Full Professional) | English (Full Professional) | Dutch (Native or Bilingual)

Skills

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.

Project history

On request per email.

Bayer HealthCare
Consultant (extern)- Global Drug Safety Manager
09.2012 - 07.2014

Global Drug Safety at Bayer Health Care- Animal Health

Alfasan International BV
Regulatory Affairs Manager/ QPPV
06.2006 - 06.2012

Generic Veterinary Medicines
-Clinical Drug Development
-BE Studies/ Residue Studies injectables for cattle, pigs, sheep, horses, dogs.
-Regulatory Affairs Veterinary Medicines 101 countries
-Pharmacovigilance/ EU QPPV Veterinary Medicines
-Veterinary Technical Issues
-Project Management

Diergeneeskundig Memorandum
Editorial Staff Member
06.2006 - 06.2012

G.I. Pharma Consultancy B.V.
Consultant
06.2009 - 05.2012

Controller within gastro-intestinal projects. Writing Sponsor requests. Lay-out/ Edit written gastro-intestinal articles for well known gastro-enterology magazines. Organizing press/ printer on time. Organizing travel schemes. Everything on the right place at the right time!

Diverse Small Animal Clinics
Veterinarian- Companion Animals
01.2001 - 05.2006
Small Animal Veterinarian and horses


 

Local Availability

Only available in these countries: Germany
2-3 Days/ week on site is possible depending on distance, remote preferrable from independant office in Germany.
Profileimage by Anonymous profile, International Consultant @ Vet-Online Consultancy, Freelancer Drug Safety and Regulatory Affairs International Consultant @ Vet-Online Consultancy, Freelancer Drug Safety and Regulatory Affairs
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