Location: Switzerland - Glattbrugg/Zurich
Function: Drug Safety/Pharmacovigilance
Company: Vifor Pharma
We are currently hiring a Head Drug Safety Case Management for our dynamic Global Drug Safety Team. Reporting into the Global Head Drug Safety Operations, in this role you will take the ownership of the case management processes at Vifor Pharma Headquarters in Zurich, and will be responsible for ensuring the individual safety reporting compliance of cases received from both spontaneous and solicited sources.
Your responsibilities will include:
- Ensure that easily scalable case management procedures are established according to the regulatory requirements; ensure high level efficiency of such procedures
- Ensure proper resource planning for case processing activities including Service Provider related planning
- Ensure that data entry convention is robust and in line with all health authority requirements and guidelines as appropriate
- Ensure that the regulatory reporting matrix of individual safety cases towards Health Authorities is kept up to date on ongoing basis
- Ensure compliant expedited reporting to regulatory agencies
- Ensure case management related tasks to support Clinical Trials are handled appropriately and reporting is in compliance with applicable regulations
- Ensure timely and appropriate data presentation for PSURs, other aggregate reports, benefit-risk assessment, signal detection and risk management activities
- Ensure that the procedural documentation is maintained and kept up to date on ongoing basis and ensure compliance with SOPs;
- Ensure the tracking, management and completion of case management related deviations and CAPAs
- Enhance all aspects of case management procedures
- Liaise with Vifor Departments, Consultants and Service Providers
- Liaise with PV compliance group for affiliates and partners for expedited compliance measure
- Liaise with the Drug Safety Infrastructure & Data Management in all aspects of E2B reporting; database and application management; retrieval; custom reporting
- Liaise with Drug Safety Alliance Management
- Liaise with Drug Safety Leads in Medical and Clinical Drug Safety regarding safety issue workups and risk assessment
- Provide input to Safety Data Exchange Agreements and
- Pharmacovigilance System Description documents
- Support replying to medical and scientific inquiries
- Support DS Operations in IT developments and implementations related to case management
We would like to welcome the following experience and skills for the role:
- University degree in pharmacology / medicine / healthcare/other life sciences
- Minimum 5 years experience in the area of pharmacovigilance
- Minimum 2 years management experience in drug safety operations / case management (team leadership, people management)
- Good understanding of PV regulatory requirements (EU GVP, US FDA)
- Good understanding of aggregate reporting; benefit-risk assessment; signal detection and risk management
- Fluency in English
- Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Experience with drug safety databases (especially ARISg); MedDRA, E2B reporting, IDMP
- Experience in PV Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management
- Project management training / experience
- German or French language skills
Your strong interpersonal skills, problem and solving attitude will help you to build relationships across the business and support the strategy to achieve our business goals. Thanks to your outstanding analytical skills, life science and pharmaceutical knowledge, you will communicate effective with stakeholders at all levels and become a trusted member of the Medical Affairs team.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.