Global Pharmacovigilance Operations Specialist

6 days ago

Belgrade, Central Serbia Hemofarm A.D. Full time 40,000 - 80,000 per year

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 Pharmacovigilance Operations Specialist

Place of work
: Belgrade

Type of contract
: Fixed term – Maternity leave

About the job:
As a Global Pharmacovigilance Operations Specialist, you will manage Risk Management Plans (RMPs), perform key pharmacovigilance activities, and monitor regulatory updates to ensure timely label changes. Your role will include signal detection, medical risk assessments, evaluating Individual Case Safety Reports (ICSRs), and supporting business development initiatives. Be a part of a team dedicated to ensuring compliance, patient safety, and driving global healthcare excellence.

Responsibilities:

  • Planning and preparation of Risk Management Plans (RMPs)
  • Communication of additional Risk Minimisation Measures (aRMM) and additional PV Activities (aPVA) to concerned Local Pharmacovigilance Units (LPUs) and GPU
  • Performance of routine Pharmacovigilance Activities resulting from RMPs (e.g. Targeted Questionnaires)
  • Monitoring of EMA/EC websites for PSUSA and referral outcomes and timely initiation of label changes via the safety variation process
  • Review of PV-related publications (e.g. CMDh, PRAC, CHMP Meeting Minutes, CMDh Press Release)
  • Signal detection, validation and medical/pharmacological assessment of signals related to STADA medicinal products
  • Preparation of Medical Risk Assessments and Clinical Overviews for safety variations
  • Support business development regarding the evaluation of new projects
  • Medical and pharmacological evaluation of Individual Case Safety Reports (ICSRs) from spontaneous and solicited sources, scientific literature and Competent Authorities.

Qualification:

  • 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.

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