Global Pharmacovigilance Specialist

Highly Competitive
  1. Permanent
  2. Pharmacovigilance
  3. Germany
Frankfurt, Germany
Posting date: 23 Nov 2023

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Global Pharmacovigilance Specialist to join a pharmaceutical organisation. This role is on a permanent basis and is located in Germany.


  • You will prepare "health hazard evaluations" in the case of drug risks due to product quality defects.
  • Serve as a representative for the division as well as contribute to preparing and following up on GxP audits and inspections.
  • Responsible for risk management and the development of risk management plans.
  • Accountable for the Medical/pharmacological review of individual case reports/adverse event reports from the international spontaneous reporting system and clinical trials.
  • Preparation of periodic safety reports (e.g., DSUR, PSUR).
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Educated to a degree level in pharmacy.
  • Demonstrable experience within a research-based pharmaceutical organisation or CRO.
  • Familiarity working in safety databased and medical coding such as MedDRA.
  • Expertise in both German and European pharmaceutical legislation and of pertinent ICH and FDA regulations.
  • Excellent knowledge of German and European pharmaceutical legislation as well as good knowledge of pertinent ICH and FDA regulations.
  • Fluency in the English language.
  • Communication skills both verbally and in writing.

If you are having difficulty in applying or if you have any questions, please contact Marius Busch at +49 69 5060 7608.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.