Global ICSR (Individual Case Safety Report Management) Specialist
Job Description
Company:  Hemofarm A.D.
Department:  PHARMACOVIGILLANCE TEAM
Job Location (Long): 

United Kingdom

Country / Region:  United Kingdom
Job level:  All target groups

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Information at a Glance

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 I 

Place of work: Belgrade

Type of contract: Fix term - Maternity cover

 

About the job:

As Specialist Global PV Operations I in the area of signal and risk management for pharma-covigilance (PV), you will work in a global function, take over the detection and assessment of safety signals from various sources and perform risk management related activities in the Global PV System of the STADA Group.

 

Responsibilities:

  • Signal detection, validation and medical/pharmacological assessment of signals related to STADA medicinal products
  • Scientific literature search for safety signals and assessment
  • Review of PV-related publications (e.g. CMDh, PRAC, CHMP Meeting Minutes, CMDh Press Release) Monitoring of EMA/EC websites for PSUSA and referral outcomes and timely initiation of label changes via the safety variation process
  •  Management and preparation of Risk Management Plans (RMPs)
  • Performance of routine Pharmacovigilance Activities resulting from RMPs (e.g. Targeted Questionnaires)
  • 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

 

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.