Medical Writer I - Pharmacovigilance

Medical Writer I - Pharmacovigilance

PrimeVigilance

Zagreb, Croatia

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);
• 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.