PV Medical Writer II
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 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
Nice To Haves
- Masters or PhD is desirable
- Fluency in English, an additional language is a benefit
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
