Pharmacovigilance QA Specialist

For our Prague headquarters we are looking for a qualified person to join us in the role of Quality Assurance Specialist (Pharmacovigilance and ISO 9001).

The ideal candidate should meet the following criteria:

  • University education in life sciences or healthcare
  • Prior experience in CRO/Pharma/Biotech in the field of Pharmacovigilance or Quality Assurance
  • Knowledge of EU and FDA Regulations as well as Guidelines on Good Pharmacovigilance Practice (GVP) and ICH Guidelines
  • Fluent in English; additional languages a plus, but not required
  • Excellent interpersonal and communication skills, including good presentation and report writing skills
  • Strong computer skills
  • Meticulous attention to detail
  • Self-motivation, determination and confidence in your abilities
  • Ability to work to deadlines, under pressure
  • Ability to work on your own initiative and as part of a team

The key responsibilities will include but may not be limited to:

  • Manage and conduct internal and third-party audits to assure compliance with PharmInvent and/or client´s procedures and local and global regulatory requirements as well as contractual agreements
  • Document audit findings and recommendations and identify process improvement initiatives and document them in an audit report
  • Generate and monitor audit and CAPA metrics and performance evaluation
  • Prepare audit strategy, SOPs, guidelines and other documented procedures required for auditing activity
  • Participate in Quality Check activities
  • Keep up-to-date about the relevant regulations, legislation of Pharmacovigilance and ISO 9001, participate in relevant seminars and trainings
  • Create/develop and present training to staff on applicable regulatory requirements

We offer following conditions:

  • Competitive salary with very attractive performance based bonus program
  • Extensive and specialized trainings
  • Dynamic and international team in a fast growing company
  • Generous benefits (life/pension fund contribution, meal vouchers, beverages and fruits at the office)
  • Office based in the center of Prague

If you are interested in this position, please send your CV and motivation letter to hr@pharminvent.com

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