Medical Writer I - Pharmacovigilance

Medical Writer I - Pharmacovigilance

PrimeVigilance

Warsaw, Poland

Job Description

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)
• Strong previous experience 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
• Ability to effectively train and mentor Associate Medical Writers
• Must be a strong team player
• Fluency in English, an additional language is a benefit

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