Medical Writer I Pharmacovigilance

Ergomed

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profile Job Location:

Zagreb - Croatia

profile Monthly Salary: Not Disclosed
Posted on: 25-10-2025
Vacancies: 1 Vacancy

Job Summary

We are looking for a pharmacovigilance medical writer to join our team. The  Medical Writer will be responsible for medical writing including:

  • PSURs/PBRERs
  • PADERs
  • ACOs
  • DSURs
  • RMPs
  • QC and review of all written output from the operations team as required
  • Supporting the project managers to determine scheduling of the aggregate reports for which they are responsible
  • In conjunction with the Quality Compliance and Training Manager identify areas for improvement and address via training clarifying changes to SOPs/OGs/templates
  • Complete quality documentation of aggregate reports
  • Attending kick off meetings with new clients as required
  • Attending audits and inspections as required
  • Providing aggregate report training

Qualifications :

  • MD pharmacy or Life Science degree (Masters or PhD is desirable)
  • Ideally experience/knowledge in Pharmacovigilance (case processing signal detection or risk management) within ideally a CRO environment 
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail
  • Good communications skills
  • Must be a strong team player
  • Fluency in English an additional language is a benefit

Additional Information :

Why PrimeVigilance 

We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

We offer: 

  • Training and career development opportunities internally  
  • Strong emphasis on personal and professional growth 
  • Friendly supportive working environment 
  • Opportunity to work with colleagues based all over the world with English as the company language 

Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!  

  • Quality 
  • Integrity & Trust  
  • Drive & Passion  
  • Agility & Responsiveness  
  • Belonging 
  • Collaborative Partnerships  

Come and join us in this exciting journey to make a positive impact in patients lives. We look forward to welcoming your application. 


Remote Work :

No


Employment Type :

Full-time

We are looking for a pharmacovigilance medical writer to join our team. The  Medical Writer will be responsible for medical writing including:PSURs/PBRERsPADERsACOsDSURsRMPsQC and review of all written output from the operations team as requiredSupporting the project managers to determine scheduling...
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Key Skills

  • Clinical Research
  • Adobe Acrobat
  • FDA Regulations
  • Technical Writing
  • Biotechnology
  • Clinical Development
  • Clinical Trials
  • Microsoft Powerpoint
  • Research Experience
  • Document Management Systems
  • Word Processing
  • Writing Skills

About Company

Company Logo

Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. ... View more

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