Global Head of PADER Reporting

  • Full-time
  • Department: Intelligence & Analytics

Company Description

PrimeVigilance covers the entire product life cycle, assisting global clients with the effective management of their drug safety information. We also have a quality resource for concise Medical Information provision made up of highly trained, industry experienced healthcare professionals.  The organisation is also a proud winner of the Queen's Award for the second time in 2019.

Job Description

Build and lead the Global Periodic and Aggregate Reporting Department for FDA submissions.  Responsible for the global management, scheduling, tracking, preparation and analysis of FDA Periodic Reports and Aggregate Reports  (e.g. PADERs) and the preparation of other special client reports related to any of the following areas: OTC, Spontaneous, Legal, any/or Clinical. 

Qualifications

  • Life science graduate, pharmacy, nursing or other healthcare qualification.  
  • 7+ years of work experience in pharmacovigilance, including 2+ years of experience in managerial position
  • Working knowledge of FDA regulations and regulatory reporting requirements related to safety
  • Proficient knowledge of drug safety databases
  • Proficient in adverse event case management
  • Working knowledge of worldwide regulatory safety reporting requirements
  • Sound knowledge of MedDRA dictionary
  • Organization skills, including attention to detail and multitasking
  • Management skills, including time management and issue management
  • Communication skills
  • Presentation skills
  • Leadership skills and ability to motivate/coach people

Additional Information

Come and be part of an organisation that is experiencing steady growth and committed to rewarding talent.  As an employee, you will belong to a global team of highly professional individuals working together to contribute to the health of people around the world.

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