Do you bring subject matter expertise in Drug Safety Data Management? Do you enjoy managing teams and external service providers?
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 Data Management reporting directly to the Global Head of Medical & Clinical Drug Safety. Your task and responsibilities will include, but not be limited to, the following :
Act as lead expert for data management in the ARISg projects, perform data cleaning related to the version change, data migration and data entry conventions updates
Maintain Standard Operating Procedures for data management, including data entry conventions, standardised searches, reports and data cleaning
Manage the data entry conventions for safety database in line with the most recent regulatory requirements
Regularly train ARISg users (internal and contracted) on data entry conventions and validations
Retrieve and present drug safety data for signal detection / Health Authority responses / reconciliation / aggregate safety reports purposes in a standardised and documented manner
Correct and respond to Health Authority data quality reports
Provide monthly reporting and case statistics, provide regular and ad hoc search results
Lead managing, defining and validating the Business Objects reports (create
User Requirement Specifications, execute validation scripts, manage validation documentation) and ensure safe user access and execution
Ensure ICH E2B (R2) standards are met, prepare system and procedures for ICH E2B (R3) implementation
Manage regular updates of the medical dictionaries in the Drug Safety database and ensure all Global Drug Safety users are appropriately trained
Participate in the user community of the safety system / MedDRA / WHO-Drug Dictionary
Team management responsibilities for three externals
The ideal candidates is holding a university degree in a pharmaceutical or information systems related in addition to the following experience :
Minimum of 3-5 years of working experience in post marketing surveillance / drug safety / data management
Drug coding and narratives / data management field including : EudraVigilance, E2B, custom reports, validation
Experience with drug safety databases (especially ARISg), E2B, Business Objects, good understanding of aggregate reporting;
benefit-risk assessment; signal detection and risk management
Experience in PV Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management
People management training / experience
Fluency in English
Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
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 affiliates and headquarters employees, work effectively in cross-
functional teams. You work in line with the Vifor Pharma values.