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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: Belgrade, Serbia
Department: Medical Writing
Employment Type: Full-time
Company: PrimeVigilance (Part of Ergomed Group)


About PrimeVigilance

PrimeVigilance is a mid-sized, specialised pharmacovigilance service provider established in 2008. With sustained global growth, the company has teams across Europe, North America and Asia delivering services in:

  • Medical Information

  • Pharmacovigilance

  • Regulatory Affairs

  • Quality Assurance

They support pharmaceutical and biotechnology companies of all sizes and cover all therapeutic areas, including medical devices. PrimeVigilance strongly prioritizes:

  • Employee training & development

  • Mental health and well-being

  • Work–life balance

  • Long-term, high-quality client partnerships


Role Summary

The Medical Writer I – Pharmacovigilance will be responsible for developing, reviewing, and quality-checking aggregate safety reports, ensuring alignment with regulatory guidelines and internal standards.


Key Responsibilities

Aggregate Report Writing

Preparation, QC, and review of the following documents:

  • PSURs / PBRERs

  • PADERs

  • ACOs

  • DSURs

  • RMPs

Quality & Compliance

  • Quality check of written outputs from operations teams

  • Completing all quality-related documentation

  • Identifying process improvement needs with the Quality, Compliance & Training Manager

  • Contributing to updates of SOPs, Operational Guidelines, and templates

  • Delivering training for aggregate report processes

Project & Client Support

  • Supporting Project Managers in scheduling aggregate report timelines

  • 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 or experience in pharmacovigilance (case processing, signal detection, risk management)

  • Experience within a CRO environment is desirable

Skills

  • Strong attention to detail

  • Ability to manage multiple tasks and prioritize effectively

  • Good communication skills

  • Strong teamwork capabilities

  • Fluency in English (additional languages are a plus)


Why Join PrimeVigilance?

  • Inclusive, diverse, equal-opportunity workplace

  • Human-centered culture focused on employee well-being

  • Structured training and internal career development

  • Friendly, supportive global environment

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

Core Values

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships