PV Quality Assurance Specialist

Would you like to step further in your pharmacovigilance career? Come and join us in the role of PV Quality Assurance Specialist within fast growing pharma consultancy company, based in the wonderful city of Prague.

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 is a big plus
  • 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

Your responsibilities during the first three months will be:

  • If not expert in this area, you will quickly become familiar with Pharmacovigilance and ISO 9001
  • Pass all necessary trainings for internal PharmInvent processes
  • Participate in Quality Check activities

Your responsibilities during the first year:

  • 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
  • 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 the following conditions:

  • Interesting and various job duties, possibility for traveling
  • Competitive salary plus performance and responsibility based bonuses (paid monthly and annually)
  • Dynamic team in a fast-growing company
  • Multicultural environment, daily use of English
  • Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
  • Language and soft skills courses
  • Generous benefits (life/pension fund contribution, meal vouchers, beverages and fruit at the office, teambuilding and company events etc.)
  • Office based in the center of Prague, Czech Republic

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

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