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Vifor Pharma

22.06.2022

Pharmacovigilance Quality Assurance Manager/ Auditor

  • Switzerland - Zurich
  • Festanstellung 100% | Management / Kader

  • Home Office
  • Merken
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Vifor Pharma

Die Vifor Pharma Gruppe ist ein globales Pharmaunternehmen. Sie hat sich zum Ziel gesetzt, globale Marktführerin in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu werden. Das Unternehmen ist ein bevorzugter Partner für Pharmaprodukte und innovative, patientenorientierte Lösungen. Die Vifor Pharma Gruppe will Patienten mit schweren und chronischen Krankheiten auf der ganzen Welt dabei helfen, ein Leben in besserer Gesundheit zu führen. Das Unternehmen entwickelt, produziert und vermarktet pharmazeutische Produkte für eine optimale Patientenversorgung. Die Vifor Pharma Gruppe nimmt in allen ihren Kerngeschäften eine führende Position ein und besteht aus folgenden Unternehmen: Vifor Pharma und Vifor Fresenius Medical Care Renal Pharma (ein gemeinsam mit Fresenius Medical Care geführtes Unternehmen).
 
Die Vifor Pharma Gruppe ist ein globales Pharmaunternehmen. Sie hat sich zum Ziel gesetzt, globale Marktführerin in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu werden. Das Unternehmen ist ein bevorzugter Partner für Pharmaprodukte und innovative, patientenorientierte Lösungen. Die Vifor Pharma Gruppe will Patienten mit schweren und chronischen Krankheiten auf der ganzen Welt dabei helfen, ein Leben in besserer Gesundheit zu führen. Das Unternehmen entwickelt, produziert und vermarktet pharmazeutische Produkte für eine optimale Patientenversorgung. Die Vifor Pharma Gruppe nimmt in allen ihren Kerngeschäften eine führende Position ein und besteht aus folgenden Unternehmen: Vifor Pharma und Vifor Fresenius Medical Care Renal Pharma (ein gemeinsam mit Fresenius Medical Care geführtes Unternehmen).
 

Pharmacovigilance Quality Assurance Manager/ Auditor

Vifor Pharma, a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, is experiencing rapid growth due to pipeline realization and optimization. 
 
We are currently looking for a Pharmacovigilance Quality Assurance Manager / Auditor to join us at our Headquarters in Glattbrugg. In this exciting position, you will be  conducting  the pharmacovigilance audits, supporting as per annual audit programme the internal PV audits and PV inspections by Regulatory Authorities and Commercial Partners and performing Good Pharmacovigilance Practices (GVP) related activities such as support in drug safety activities (the conduct of audits, procedural documents review, projects, etc.). You will be directly reporting to Pharmacovigilance Quality Assurance Management Lead.
 
Key Tasks:
  • Comply with all corporate policies, rules, and regulations as set out and communicated by the company pursuant to good business practice
  • Independently conduct external & internal audits for QM CMRS (included but not limited to affiliate, commercial partners and vendor audits)
  • Auditing of directed and for-cause audits as necessary
  • Monitor audit responses and Corrective and Preventive Actions (CAPAs) to ensure accuracy and completeness
  • Act as PV QA representative in designated global drug safety team activities and internal guidance and consulting for GVP issues
  • Conduct drug safety documents compliance verification (e.g. Pharmacovigilance System Master File, procedural documents etc.) as assigned
  • Management of Audit and Deviation CAPA (tracking, oversight, follow-up and effectiveness)
  • Audit/inspection documentation management and maintenance (including audit/inspection logs)
  • Generate and provide PV QA metrics, status and other information in relation with GVP, as required by management
  • Perform other duties as assigned, e.g. GVP training, support Head PV QA in authority inspection preparation, conduct and post-inspection activities
  • Provide PV training (basic, annual or refresher) to staff as well as special training groups from business and sales. Support with preparation and review of training materials
  • Write procedures, as well as monitor and assess global safety and quality processes and procedures for consistency and with global laws, regulatory requirements and Vifor Pharma policies and procedures
  • Management of assigned projects as Team member, QA representative or Project Lead
Qualifications
  • The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.
  • University degree or equivalent in health sciences, nursing, pharmacy or related field.
  • Minimum of 2 years’ experience in GVP auditing with Food and Drug Administration / European Medicines Agency / Global regulatory requirements and International Conference on Harmonization / GVP guidelines (monitoring and/or drug safety or clinical operations experience will be considered)
  • Experience in regulated environment, preferably pharmaceutical industry
  • This role involves up to 40% travel
  • High ethical standards and integrity
  • Ability to work well independently and in a team environment, interact productively and effectively with peers, management and third parties
  • Proficiency with Microsoft (MS) Office including Word, Excel and PowerPoint
  • Ability to maintain a high level of confidentiality
  • Use resources effectively and reasonably
  • Excellent oral and written communication skills
  • Strong interpersonal and organisational skills
  • Flexibility, recognition of occasional unusual working hours due to international nature of operations
  • Multilingual an asset
  • User experience in TrackWise an asset
Vifor Pharma
Pharmacovigilance

Arbeitsort:

Switzerland - Zurich(Home Office möglich)

Diana Agovska
Talent Acquisition Manager