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Medical Writer I - Pharmacovigilance

0-2 years
Not Disclosed
10 Nov. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Medical Writer I – Pharmacovigilance

Location: Zagreb, Croatia
Department: Medical Writing
Employment Type: Full-time
Company: PrimeVigilance (Part of Ergomed Group)


About PrimeVigilance

PrimeVigilance is a specialised mid-size pharmacovigilance service provider founded in 2008. The company has experienced continuous global growth, with teams across Europe, North America, and Asia delivering high-quality services in:

  • Medical Information

  • Pharmacovigilance

  • Regulatory Affairs

  • Quality Assurance

The organisation supports pharmaceutical and biotechnology clients of all sizes and across all therapeutic areas, including medical devices. PrimeVigilance is committed to:

  • Employee development and training

  • Well-being and mental health

  • Work–life balance

  • Long-lasting client partnerships


Role Overview

The Medical Writer I – Pharmacovigilance will prepare, review, and ensure the quality of aggregate safety reports and related documentation in compliance with regulatory guidelines and company standards.


Key Responsibilities

Aggregate Report Writing

Preparation, quality checking, and review of:

  • PSURs / PBRERs

  • PADERs

  • ACOs

  • DSURs

  • RMPs

Quality & Compliance

  • Review of written output from operations teams

  • Completing required quality documentation for aggregate reports

  • Identifying process improvements with the Quality, Compliance & Training Manager

  • Supporting updates to SOPs, Operational Guidelines, and templates

  • Delivering training related to aggregate report processes

Project & Client Interaction

  • Supporting Project Managers in scheduling aggregate reports

  • Attending kick-off meetings with new clients

  • Participating in audits and inspections as required


Qualifications

Education

  • MD, Pharmacy, or Life Science degree

  • Master’s or PhD preferred

Experience

  • Knowledge/experience in Pharmacovigilance (case processing, signal detection, risk management)

  • CRO experience is desirable

Skills

  • Strong attention to detail

  • Ability to prioritise and manage multiple tasks

  • Excellent communication skills

  • Strong teamwork abilities

  • Fluency in English (additional languages advantageous)


Why Join PrimeVigilance?

  • Inclusive and diverse work environment

  • Emphasis on employee well-being and development

  • Internal training and career growth opportunities

  • Supportive and collaborative global team

  • Opportunity to work with international colleagues (English as the main company language)

Core Values

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships