Medical Writer I – Pharmacovigilance
Location: Kraków, Poland
Department: Medical Writing
Employment Type: Full-time
Company: PrimeVigilance (Part of Ergomed Group)
About PrimeVigilance
PrimeVigilance is a specialised, mid-sized pharmacovigilance service provider established in 2008. The company has achieved consistent global growth, with teams across Europe, North America, and Asia delivering services in:
Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance
The company supports pharmaceutical and biotechnology companies of all sizes and covers all therapeutic areas including medical devices. PrimeVigilance emphasises:
Strong employee training & development
Work–life balance
Well-being and mental health
Long-term client relationships and high-quality service delivery
Role Summary
The Medical Writer I – Pharmacovigilance will be responsible for preparing, reviewing, and ensuring the quality of aggregate safety reports, while supporting project teams and contributing to continuous process improvement.
Key Responsibilities
Aggregate Safety Report Writing
Preparation, QC, and review of:
PSURs / PBRERs
PADERs
ACOs (Annual Company Reports)
DSURs
RMPs
Quality & Compliance
Reviewing written outputs from operations teams
Completing all quality documentation related to aggregate reports
Identifying process improvement areas with the Quality, Compliance & Training Manager
Contributing to updates in SOPs, Operational Guidelines, and templates
Delivering aggregate report training
Project & Client Support
Supporting Project Managers in planning and scheduling aggregate report timelines
Attending client kick-off meetings
Participating in audits and inspections as required
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)
Experience in a CRO environment is advantageous
Skills
Strong written and verbal communication
High attention to detail
Ability to manage multiple tasks and prioritise effectively
Strong team collaboration skills
Fluency in English (additional languages are a plus)
Why Join PrimeVigilance?
Equal opportunity and inclusive work environment
Human-centric culture focused on well-being
Excellent training and career development opportunities
Supportive, friendly global team
Work with colleagues worldwide (English is the company language)
Core Values
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Gujarat :
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