PrimeVigilance, an Ergomed company, was established in 2008 by former Drug Regulators, to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO definition of pharmacovigilance). Since then, PrimeVigilance has added other services including medical information call centres, and has grown to become one of the global leaders in its field, providing services to over 150 client companies in more than 100 countries. We continue to expand as we strive to become the leading global pharmacovigilance and medical information service provider. Our Mission is a world with safer drugs.

We are looking for an experienced pharmacovigilance medical writer to join our team. The  Medical Writer will be responsible for medical writing including:

• PSURs/PBRERs
• PADERs
• ACOs
• DSURs
• RMPs
• CSEs
• Signal detection reports
• PSMF
• 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

• 3 years’ experience of pharmacovigilance medical writing, including 2 years PSUR writing
• Life Science degree, or have equivalent nursing or medical qualifications
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Ability to effectively train and mentor Associate Medical Writers
• Advanced knowledge of English

Our Offer

• Competitive salary
• Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
• Friendly working environment with several social events per year