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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: Sarajevo, Bosnia and Herzegovina
Department: Medical Writing
Employment Type: Full-time
Company: PrimeVigilance (Ergomed Group)


About the Company

PrimeVigilance, part of the Ergomed Group, is a global, specialised pharmacovigilance service provider established in 2008. The company has grown organically with teams across Europe, North America, and Asia, offering high-quality services in:

  • Pharmacovigilance

  • Medical Information

  • Regulatory Affairs

  • Quality Assurance

PrimeVigilance supports pharmaceutical and biotechnology companies across all therapeutic areas, including medical devices. The organisation prioritizes:

  • Strong training & development

  • Employee well-being and mental health

  • Work–life balance

  • Long-term partnerships and high-quality service delivery


Role Overview

The Medical Writer (Pharmacovigilance) will prepare and review a wide range of safety and aggregate reports, support project teams, and contribute to continuous quality improvement and training activities.


Key Responsibilities

Medical Writing & Safety Reports

Preparation, review, and QC of:

  • Periodic Safety Update Reports (PSURs/PBRERs)

  • Periodic Adverse Drug Experience Reports (PADERs)

  • Annual/Ad-hoc Company Reports (ACOs)

  • Development Safety Update Reports (DSURs)

  • Risk Management Plans (RMPs)

Quality & Compliance

  • Perform QC/review of written deliverables from operations teams

  • Complete quality documentation for all aggregate reports

  • Identify process improvements with the Quality, Compliance, and Training Manager

  • Contribute to SOP, operational guidance, and template updates

  • Deliver training on aggregate reports

Project Support

  • Support Project Managers in scheduling aggregate safety reports

  • Participate in client kick-off meetings

  • Attend audits and regulatory inspections when required


Qualifications & Skills

Education

  • Degree in Medicine, Pharmacy, or Life Sciences

  • Master’s/PhD preferred

Experience

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

  • Experience in a CRO environment is an advantage

Skills

  • Strong written communication

  • Excellent attention to detail

  • Ability to prioritize and handle multiple projects

  • Team-oriented mindset

  • Fluency in English (additional languages are a plus)


Why Join PrimeVigilance?

  • Strong focus on diversity, inclusion, and equal opportunity

  • Human-centric work culture

  • Excellent internal training and development opportunities

  • Supportive, global working environment

  • Collaboration with international teams

  • Company values:

    • Quality

    • Integrity & Trust

    • Drive & Passion

    • Agility & Responsiveness

    • Belonging

    • Collaborative Partnerships