Medical Writer II

PrimeVigilance

1d

About The Position

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. This role also involves 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, the Medical Writer will identify areas for improvement and address via training, clarifying changes to SOPs/OGs/templates. The role includes completing quality documentation of aggregate reports, attending kick-off meetings with new clients as required, and attending audits and inspections as required. Additionally, the Medical Writer will provide aggregate report training.

Requirements

• 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

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level