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 - PVA
Place of work: Belgrade
About the job: As a Specialist Global PV System (PVA), you will manage and coordinate pharmacovigilance agreements and collaborations with global partners, ensure compliance, support audits, and maintain key PV system documentation.
Responsibilities:
- Coordination of pharmacovigilance (PV) collaborations with contractual partners world-wide within the Global PV System
- Preparation and review of PV Agreements (PVA) and communication with contractual partners
- Maintenance, tracking and periodic review of PVAs including PVA database manage-ment
- Monitoring the implementation of PV activities resulting from PVAs within the Global PV System
- Support of Local Pharmacovigilance Units in terms of PVAs and collaboration with con-tractual partners
- Support PV audits and inspections
- Compliance monitoring and tracking of Corrective Action /Preventive Action
- LCP-PV Management (registration/de-registration for the Global PV System)
- Maintenance of the Pharmacovigilance System Master File (PSMF)
- Writing and updating of working instructions (SOPs and OPs).
Qualifications:
- University degree and professional experience in the pharmaceutical industry in the area of pharmacovigilance
- 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.