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Pharmacovigilance Medical Writer II

Pharmacovigilance Medical Writer II

PrimeVigilanceWarsaw, Masovian Voivodeship, Poland
7 days ago
Job type
  • Remote
Job description

Job 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

Qualifications

  • 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

    • 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 :

  • 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

    • 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!

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships

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

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    Pharmacovigilance • Warsaw, Masovian Voivodeship, Poland