Pharmacovigilance Specialist

Vor 5 Tagen

Dresden, Sachsen, Deutschland GULP Information Services GmbH Vollzeit 70.000 € - 90.000 €/Jahr

For our client, an innovative and internationally operating pharmaceutical company in Dresden, we are seeking a dedicated Specialist Complaint Management & Pharmacovigilance / Step‑By‑Step Plan Officer (m/f/d) for direct placement. In this responsible key position, you will manage complaints and drug safety and can quickly assume the role of Step‑By‑Step Plan Officer. We place great value on equal opportunities and diversity; therefore, we expressly welcome all applications. Recording, evaluating, and processing adverse drug reaction reports (ICSRs), including follow‑up, literature searches, and data reconciliation with international partners. Holistic management of drug complaints in close coordination with internal interfaces, customers, and distribution partners. Coordination and professional handling of complex medical‑pharmaceutical customer inquiries. Creation and optimization of SOPs, as well as active support for training, audits, GMP inspections, and process improvements. Potential or direct assumption of the statutory function as the Stufenplanbeauftragter (Section 63a AMG) or Informationsbeauftragter (Section 74a AMG).

  • Successfully completed university studies in pharmacy, human medicine or a comparable natural science
  • Several years of relevant professional experience in the pharmaceutical industry, ideally in a GMP‑regulated environment or quality management
  • Sound practical knowledge and experience for the timely assumption of duties as a Stufenplanbeauftragter (§ 63a AMG)
  • Fluent German and English skills, both spoken and written, are required.
  • Excellent communication skills, a meticulous and independent work ethic, and a passion for interdisciplinary collaboration.