Key skills
Risk Management
About this role
Role Overview
- 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
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
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment