Pharmacovigilance Medical Writer II

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

Qualifications :

Additional Information :

Why PrimeVigilance

We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer :

Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!

Come and join us in this exciting journey to make a positive impact in patients lives. We look forward to welcoming your application.

Remote Work : No

Employment Type : Full-time

Key Skills

Clinical Research,Adobe Acrobat,FDA Regulations,Technical Writing,Biotechnology,Clinical Development,Clinical Trials,Microsoft Powerpoint,Research Experience,Document Management Systems,Word Processing,Writing Skills

Experience : years

Vacancy : 1