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 Operations II 

Place of work: Belgrade

About the job:

As Specialist Global PV Operations II in the area of Periodic Safety Update Reports (PSURs) and EU referrals for pharmacovigilance (PV), you will work in a global function, take over the preparation of PSURs and perform safety assessments in the Global PV System of the STADA Group.

Responsibilities:

• Planning, preparation and medical writing of Periodic Safety Update Reports (PSURs) and Addendum to Clinical Overview (AdCO) for renewals of Marketing Authorisations of STADA Group companies worldwide
• Literature search and scientific evaluation of literature articles for PSURs and AdCOs
• Monitoring of updates for PSUR planning according to regulatory requirements
• Tracking of PSUR assessment reports and internal communication of assessment outcome
• Writing response documents to requests from Competent Authorities for PSUR assessment reports and referral procedures
• Administrative support for the maintenance of Reference Safety Information
• Support of Local Pharmacovigilance Units of STADA affiliates worldwide in terms of PSUR and AdCO management and implementation of standard operating procedures (SOPs)
• Writing and updating of working instructions (SOPs and OPs)

Qualifications:

• University degree in pharmacy, health sciences, medicine or a related discipline
• Professional experience in the pharmaceutical industry in area of pharmacovigilance desired
• Good communication skills
• Fluent in English (orally and in writing)
• Responsible, careful and independent work
• Structured, analytic and result-oriented work style
• Very good software skills (MS-Office, databases)

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.