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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. 

 

Global ICSR (Individual Case Safety Report Management) Specialist

Place of work: Belgrade

 

About the role:  As a Global ICSR (Individual Case Safety Report Management) Specialist, you will be responsible for processing Individual Case Safety Reports (ICSRs) from various global sources, maintaining data integrity, and assisting in the regulatory compliance of pharmacovigilance activities. 

 

Responsibilities:

 

  • Processing of Individual Case Safety Reports (ICSRs) related to STADA medicinal products from sources worldwide (spontaneous reports, studies, literature, competent authorities, and contractual partners).
  • Data entry into the global Pharmacovigilance (PV) database.
  • Checking for duplicates in the database.
  • Writing narratives for the reports.
  • MedDRA coding (Medical Dictionary for Regulatory Activities coding).
  • Archiving of reports and documentation.
  • Medical and pharmacological assessment of adverse drug reactions (ADRs).
  • Quality control of data entry performed by Local Pharmacovigilance Units (LPUs) of STADA affiliates.
  • Submission of ICSR to competent authorities, the European Medicines Agency (EMA), LPUs, and contractual partners, along with timeline surveillance of ICSR reporting.
  • Writing working instructions (Standard Operating Procedures [SOPs] and Operational Procedures [OPs]) and providing support to LPUs in terms of ICSR processing.

 

Qualifications:

 

  • University degree in pharmacy, human medicine or natural sciences
  • 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, 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.

Apply now »