Specialist Global PV System

1 week ago

Belgrade, Central Serbia STADA Group Full time

Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

Specialist Global PV System
Place of work:
Belgrade

About the job
: As Specialist Global PV System in the area of quality management (QM) for pharmacovigilance (PV), you will work in a global function, take over the documentation of all compliance processes in the Global PV System of the STADA Group and provide support in PV-related QM processes.

Responsibilities:

  • Documentation of non-compliances with PV processes as laid down in standard operating procedures (SOPs) and PV Agreements with contractual partners
  • Follow up of Corrective and Preventive Actions (CAPA)
  • Electronic administration of SOPs and SOP trainings in the Quality Management Systems
  • Coordination of PV and SOP trainings including documentation and success control
  • Back-office support for PV audits and inspections (coordination, preparation and follow-up)
  • Administrative audit activities including preparation of the audit agenda, plan and report, as well as correspondence with auditees
  • Updating of the Pharmacovigilance System Master File (PSMF) including quality checks and final compilation
  • Support of Local Pharmacovigilance Units in terms of PV Quality

Qualifications :

  • University degree with preferably professional experience in the pharmaceutical industry in the area of pharmacovigilance and quality management
  • Good communication skills
  • Fluent in English (orally and in writing)
  • Responsible, careful and independent work
  • Structured, result-oriented work style
  • Very good software skills (MS-Office)

We offer:

  • Private healthcare insurance (with the option of privileged usage for family members)
  • Ongoing professional development through specialized education and training
  • A platform for learning 14 foreign languages, using various learning styles, including conversation courses
  • Personalized mental health and well-being support for employees and their families through the Kyan Health app

Only shortlisted candidates will be contacted.

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