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Pharmacovigilance Submission Specialist

2 miesięcy temu

Kraków, Polska PrimeVigilance Pełny etat
Job Description

  • Support the client in all aspects of safety reporting for aggregate reports and related activities
  • Performing submissions of aggregate reports to all concerned parties
  • Performing and oversight of reporting’s of Aggregate reports to Regulatory Authorities (RAs), Ethics Committees (ECs), Institutional Review Boards (IRB) and Investigators
  • Tracking and archiving Aggregate reports submissions and exchanges in Aggregate reports tracker and archive, and Project specific tracker and archive
  • Maintaining and oversight over aggregate and submission  tracker
  • eCTD compiling for aggregate reports
  • eCTD sequence submission to clients/relevant regulatory bodies
  • Maintaining Submissions mailbox
  • Supporting the client with EudraVigilance registration and maintenance of EudraVigilance account for client
  • Registration on behalf of client
  • Support in all PV operations associated with safety reporting for aggregate reports and related activities
  • Quality control of daily safety reporting activities
  • Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area
  • Preparing invoice data and data reports on submission and project activities of department
  • Supporting business development activities in department
  • Participating in Audits and Inspections

Qualifications

Healthcare or regulatory related qualification

IT skills

Demonstrated PV experience and submission experience required



Additional Information

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.