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.