Vifor Pharma is a world leading speciality pharmaceutical company. Our pharmaceutical business focuses on the development, manufacture and marketing of anaemia products and the development of medicines for the treatment of renal related autoimmune diseases. Our consumer healthcare business manufactures both internally developed and in-licensed products, which we market internationally.

Drug Safety Advisor
Glattbrugg

AREA OF RESPONSABILITY _

• Coordinate processing of post-authorization safety data received from worldwide sources (spontaneous, literature and others)
• Ensure appropriate tracking of inbound and outbound communication related to individual safety cases
• Coordinate work of in-contracted and outsourced resources for case processing activities
• Ensure consistency in case classification, causality, labelling, MedDRA, WHO-Drug coding and narratives
• Liaise with Other Drug Safety Advisors regarding their case processing tasks (medical evaluation, QC)
• Liaise with Consultants and Service Providers in post-marketing surveillance
• Manage the reporting matrix of post-authorization individual safety cases towards EU and non-EU Health Authorities and Contractual Partners; ensure compliant expedited reporting (time, channel, format)
• Coordinate case follow-up activities and reconciliation with Health Authorities / Contractual Partners
• Coordinate worldwide literature screening; ensure appropriateness of documentation; screen results for case inclusion and safety relevance
• Liaise with affiliates and partners for local literature, expedited compliance
• Liaise with the Drug Safety IT Specialist in all aspects of E2B reporting; database and application management; data retrieval; custom reporting
• Measure and present internal and regulatory compliance
• Ensure timely and appropriate post-authorization data presentation for PSURs, other aggregate reports, benefit-risk assessment, signal detection and risk management activities
• Liaise with Other Drug Safety Advisors in Clinical and Medical Safety regarding safety issue workups and risk assessment
• Update and maintain procedural documentation in post-marketing surveillance processes and ensure compliance; Track and manage CAPAs in post-marketing surveillance processes
• Provide input to Safety Data Exchange Agreements and Pharmacovigilance System Description documents regarding the post-marketing surveillance processes
• Conduct safety trainings for new pharmacovigilance staff and other company units
• Liaise with Quality Assurance in handling Product Technical Complaints associated with adverse events or received initially by Drug Safety
• Assists in replying to medical and scientific inquiries

YOUR PROFILE _

• University degree in pharmacology / medicine / other life sciences
• Minimum of 2 years of working experience in post marketing surveillance / drug safety operations including: case classification, causality, labelling, MedDRA, WHO-Drug coding and narratives
• 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)

WE OFFER _you a interesting and challenging function in a young, motivated team as well as the advantages of a modern company with excellent social benefits.

Are you interested in a new challenge? Send your application to:

Vifor Pharma Zürich
Ramona Roth
Flughofstrasse 61, 8152 Glattbrugg
Telefon +41 (0)58 851 80 25, prospects_zh@viforpharma.com
www.viforpharma.com