ERGOMED
Biotechnology • Pharmaceuticals • Healthcare Insurance
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
Pharmacovigilance Medical Writer II, Aggregate report writing experience required
Job not on LinkedIn
August 13
ERGOMED
Biotechnology • Pharmaceuticals • Healthcare Insurance
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
đź“‹ 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
🎯 Requirements
• MD, pharmacy or Life Science degree (Masters or PhD desirable) • Strong previous experience in Pharmacovigilance (Aggregate report writing, 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 • Opportunity to work with colleagues based all over the world, with English as the company language • Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships
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