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Associate PV Compliance / Quality Systems Manager (1 FTE)
Temporary position for approximately 1 year in the pharmaceutical industry
Het bedrijf / The company
Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is in Leiden but has a tight line all around the world. To support the compliance activities, we would like to meet an experienced Associate PV Compliance / Quality Systems Manager.
De functie / The role
As an Associate PV Compliance/ Quality Systems Manager you will support the continuous monitoring of PV Compliance, submission timeliness and quality metrics. This includes the detection of negative patterns and trends in close collaboration with internal and external stakeholders (Regulatory Affairs, Quality Assurance, Business Partners). Furthermore, you will support the preparation of PV metrics reports and presentations that include performance indicators that provide feedback to functional PV groups. You have a good understanding of the regulations concerning PV. You are able to characterize general PV Regulatory Affairs and provide more specific knowledge towards US or EU GVP regulations. Of course, you will answer with specific examples of the contribution and direct influence with Health Authority Inspections. You will report to the Director Quality Management Systems & Compliance.
Het profiel / Your profile
• more than 3 years of experience within Pharma, Quality and/or Compliance
• global experience and working with European Drug Safety Officers (DSOs) preferred
• pharmacovigilance and PV Safety Database experience required
• experience in performing Root Cause Analysis required
• knowledgeable about PV legislation required
• strong leadership skills, team player, global mindset
• ability to work effectively in a matrix setting to resolve issues and achieve common goals
• excellent listening and comprehension skills
• proficient with Microsoft Excel
Het aanbod / The offer
• a diverse job within a pharmaceutical company
• interesting because of the contribution to the Quality Systems
• a temporary contract with the possibility to extend
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-045-DD, to Sandra van Putten: email@example.com. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.
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