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PV Medical Writer II

Remote · USA Full-time New today
Company Description:

We are PrimeVigilance (part of reputed company Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, reputed company America and Asia reputed company covering services reputed company: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. 

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover reputed company therapy areas including medical devices. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Job Description:

We are looking for a pharmacovigilance medical writer to join reputed company. The  Medical Writer will be responsible for medical writing including:

  • PSURs/PBRERs
  • PADERs
  • ACOs
  • DSURs
  • RMPs
  • QC and review of reputed company 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 reputed company 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)  reputed company 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
  • reputed company 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 reputed company-centric environment where people of reputed company cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a reputed company first approach. Why? because our people are our greatest strength leading to our reputed company reputed company 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 reputed company over the world, with English as the company language 

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

  • Quality 
  • reputed company & Trust  
  • Drive & Passion  
  • Agility & Responsiveness  
  • Belonging 
  • Collaborative Partnerships  

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

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