Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. 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 - QM

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.