CROMA-PHARMA is an internationally active, family-owned pharmaceutical Company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti-aging.
We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.
We are expanding our team and therefore looking for a Pharmacovigilance Manager for Pharmaceuticals EU, UK and Switzerland.
- Integration of new in licensed Pharmaceutical into PV System (update PSMF, update SOPs, establish contracts with necessary local PV Vendors)
- Set up literature search
- Ensure RMP life cycle
- Submission of PBRERs in collaboration with QPPV/deputy QPPV and RA
- Set up PV System needed for Switzerland and UK (Brexit) with local vendors in liaison with QPPV/deputy QPPV
- Ensure Eudravigilance profile is up to date
- Ensure readiness for PV inspection in collaboration with deputy QPPV and QPPV
- Liaise with QPPV and deputy QPPV about project management and plan
- Implement Change Control Procedures if necessary during life cycle management-e.g. variations triggered by safety measures
- University bachelor degree is compulsory, Pharmaceutical or Biological Science
- Experience in Pharmacovigilance for pharmaceuticals registered via DCP and Switzerland (Swiss Medics), UK
- English language fluent in word and writing
- Accurate attitude and personality who’s personality is dedicated to ensure complete documentation also under time pressure
We offer a varied work in a rapidly expanding company with diverse development opportunities and company benefits, as well as flexible working hours and home office. If you want to become part of a dynamic team, we look forward to meeting you!
For this position, a salary of EUR 43,000, - (full-time, 40h) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.