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Pv Officer (Senior Level Position)

3+ years
Not Disclosed
10 April 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: PV Officer (Senior Level Position)
Location: Zagreb, Croatia
Job Type: Full-time
Department: ICSR Management


About the Company:

PrimeVigilance, part of Ergomed Group, is a specialized pharmacovigilance service provider established in 2008. The company has consistently experienced global organic growth, with staff based across Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance supports pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming a global leader in its field. The company invests in employee well-being, offering excellent training and development platforms, with a focus on work-life balance to ensure high-quality client service.


Job Responsibilities:

  • Case Processing:

    • Manage Individual Case Safety Reports (ICSRs) from all sources (post-marketing, clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures, and client-specific requirements

    • Perform and support pharmacovigilance activities on behalf of PrimeVigilance, covering all steps of a workflow cycle, except Medical Review

  • Independent Management:

    • Handle SAE/SUSAR submissions, unblinding, and clinical trial reconciliations

    • Prepare database outputs for periodic reporting (e.g., PBRER, DSUR, PADER)

  • Mentoring & Training:

    • Mentor and train new and junior employees within the department, optimize procedures, and contribute to their development


Required Qualifications:

  • Education:

    • Life science or biomedical background (e.g., chemistry, biology, biotechnology, veterinary science) with a healthcare-related degree

  • Experience:

    • Demonstrated experience in pharmacovigilance case processing

  • Skills:

    • Strong time and issue management, delegation, organization, and multitasking skills

    • Excellent attention to detail

    • Strong interpersonal and communication skills

    • Advanced English proficiency (C1 or above) in both verbal and written communication


Additional Information:

  • PrimeVigilance prioritizes diversity, equity, and inclusion, fostering an equal opportunities workplace where people from all cultural backgrounds, genders, and ages can contribute and grow.

  • The company adopts a human-first approach, believing its people are the greatest strength driving the continued success in improving lives globally.

  • PrimeVigilance offers internal training, career development, and a friendly, supportive working environment with colleagues from around the world.

  • Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships