Danaher Corporation Post Market Surveillance (PMS) Analyst/ Biostatistician in Kloten, Switzerland
Danaher Company Description
Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.
- The Post Market Surveillance Analyst will collaborate with a team of product managers, development engineers, clinical evaluation experts and analysts in support of post market surveillance plan and report creation.
- The Post Surveillance Analyst will support the Proactive PMS Manager in establishing a systematic PMS System according to the requirements set in the EU Medical Device Regulation.
- The Post Market Surveillance Analyst will build a working relationships with cross functional teams including Development, Supply Chain, Program Management, Commercial Operations, Regulatory Affairs, etc. to ensure process solutions are compliant, efficient and adaptable to business units, sites and functions throughout the world according to the established processes following the European, US and other applicable regulations.
Provide continuous process improvement and consultation and support of the Post Market Processes as required, at global sites.
The position will need to closely work together with the counterparts in the other sites (Belfeld) but also with the production sites where products have been produced.
Main Responsabilties will include:
Derive data from the complaint handling system in SAP and sales data in Minerva to perform the required analysis in different tools (Excel, Minitab, Access, …).
- Prepare the statistics for the quarterly PMS review meetings, conduct/perform analysis of complaints for regulatory affairs and clinical research studies.
- Executing periodical post market product data analysis processes
- Ensuring the adequacy of the documentation of post market surveillance activities in terms of regulatory compliance and technical/statistical soundness, presents results and proposes escalations, corrective, and preventative actions as required.
- Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management.
- Reviews and continuously executes the global post market surveillance process. Extracts monthly post market quality data and maintains compliant records.
- Performs post-market safety and surveillance activities including data analysis, tracking/trending and signal detection. Support the improvement of the PMS process and writing the documentation (SOP, Templates, etc.) as required by the process.
- University Master degree in Biomedical Engineering, (bio) Statistics or relevant degree Knowledge of statistics and data handling and visualization
- Knowledge of Medical Device complaint handling regulations in the EU, the US, Japan and other relevant markets
- Experience in FDA regulated company
- At least 2-3 years of relevant experience in the pharma or, preferably, medical device industry
- At least 2-3 years of relevant experience analyzing patient related data (clinical, post marketing, epidemiology, etc.). Experience with the analysis of post-marketing surveillance data is a plus
- High degree of autonomy in performing assigned duties
- Comfortable with handling large data sets in order to provide relevant insights for the business
- Sense of urgency but also steadiness in handling the daily business
- Fluency in English is mandatory. German and other languages is a plus
- SAP experience is absolutely required, as well as experience in retrieving data from databases (SQL, XML, Minerva)
- Excellent communication skills, with ability to present to top management when called for
- Strong experience with SAS programming: SAS/BASE, SAS/GRAPH, SAS/STAT SAS/MACRO
- Experience with data visualisation tools (e.g. Tableau, MS Power BI) and other statistical analysis packages (e.g. MiniTab, SPSS, R) is a plus
- Problem solving mentality
- Reliable and trustworthy
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
/ To be considered for this role, applicants must be either Swiss citizens, EU-nationals or have the legal right to live and work in Switzerland. /
For agencies : please, note that we only accept direct applications. Submission of candidates from unsolicited third parties does not create any implied obligation on the part of Nobel Biocare/ Danaher group
Organization: Nobel Biocare
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Switzerland-Zurich-Kloten
Req ID: NOB002102