Head Drug Safety Data and Infrastructure Management - Zurich

Location: Switzerland - Glattbrugg/Zurich

Function: Drug Safety/Pharmacovigilance

Company: Vifor Pharma

Georgia Izzat

International Talent Acquisition Manager

+41 58 851 83 78

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About You

Do you excel at understanding pharmacovigilance safety databases? Do you enjoy managing teams and external service providers? Do you have affinity with Data Management? If yes, we have a great opportunity for you to join our Global Drug Safety team at our Operational Headquarters in Glattbrugg. We are seeking a Head Drug Safety Infrastructure and Data Management reporting directly to the Head Global Drug Safety Technologies. Your task and responsibilities will include, but not be limited to, the following:

  • Line Management of a small team of in-house employees
  • Coordination of a larger team of outsourced externals
    Act as deputy in absence of Global Head Drug Safety Technologies
  • Act as the main interface between Pharmacovigilance and IT/Safety Database experts, translating business versus IT requirements and vice versa
  • Act as lead expert in the development and implementation of new drug safety technologies
  • Participate in cross-industry and vendor collaborations related to standardisation and technological advancements in pharmacovigilance
  • Actively contribute to technology developments of the Vifor Pharma safety database and associated pharmacovigilance IT platforms
  • Ensure maintenance, updating and validation of the global Safety Database (ARISg) for all Vifor Pharma global products, including medical dictionaries such as MedDRA, WHO-Drug
  • Act as lead expert for data management in the ARISg projects, manage data cleaning related to version changes, data migrations and data entry conventions updates
  • Maintain Standard Operating Procedures related to the safety database and pharmacovigilance data management
  • Regularly train ARISg users (internal and contracted) on safety database functionality and enhancements
  • Manage the retrieval and presentation of drug safety data for signal detection / Health Authority responses /  reconciliation / aggregate safety reports purposes in a standardised and documented manner
  • Oversee generation of monthly reporting and case statistics, provide regular and ad hoc search results
  • Lead the management, definition and validation of Business Objects reports
  • Create User Requirement Specifications, execute validation scripts and manage validation documentation
  • Ensure ICH E2B (R2) standards are met, prepare system for ICH E2B (R3) implementation

The ideal candidate is holding a university degree in any life sciences, pharmaceutical or information systems science related in addition to the following experience:

  • Minimum of 3-5 years of working experience in post marketing surveillance / drug safety / data management
  • People management training / experience
  • Experience with drug safety databases (preferably ARISg), E2B, Business Objects,
  • Good understanding of pharmacovigilance concepts such as case management, aggregate reporting,; signal detection, risk management and safety contracts management
  • Experience with coding and other pharmacovigilance data entry conventions, Distribution conditions, EudraVigilance, E2B, custom reports, validation
  • Experience in PV Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management
  • Fluency in English
  • High affinity with computerised systems
  • Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook) and preferably other systems (e.g. MS Sharepoint)

You have strong communication skills orally and in writing and good analytical skills. You are organised and accurate in your approach, with a good sense for prioritisation and the identification of critical situations from a drug safety perspective. You are able to maintain good working relationships with and able to rapidly build your network in- and outside the company. You work in line with the Vifor Pharma values.

About Us

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.

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