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
Gujarat :
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