CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.
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.
- 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
- 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 25% 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