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Associate Director Data Engineer
  • Python
  • SQL
  • SAS
  • Excel
  • Database
  • ETL
Bayer
New Jersey
146 days ago

YOUR TASKS AND RESPONSIBILITIES


The primary responsibilities of this role, Associate Director Data Engineer, are to:

  • Provide standard and specific master data and transaction data retrievals to all PV functions, internal and external partners, authorities and the Qualified Person Pharmacovigilance (QPPV) utilizing the global PV database, Oracle Empirica solutions, Business Objects, SAS, Spotfire, internal tools and external databases outside Bayer in order to support product risk/benefit, process, workload and impact analysis;
  • Advise customers and partners on providing comprehensive demand specifications based on the ability to understand PV and GxP processes, the medical background, PV data and regulations, develop bespoke analytics on different data types such as adverse event reports, quantitative drug safety statistics, workflows, workload and reporting compliance;
  • Use specific PV tool knowledge, programming and query languages to develop new queries, reports and tools for risk/benefit, process, workload and impact analysis while following software development and computer system validation rules in order to cover new demands with compliant solutions;
  • Advise on process improvements and develop their tools and representations such as signal management workflows, SOPs, other quality documents and validation activities to increase PV efficiency in a compliant manner, support inspections, their preparations and the PV Inspection Intelligence function with SME advice;
  • Translate medical, pharmaceutical and managerial business demands into IT solutions while implementing and maintaining tools and database objects for ETL algorithms, data filtering and aggregation, statistical analysis and prognosis;
  • Provide project contribution for global cross-functional projects, support audits and inspections directly, manage customer demands and expectations, provide customer relationship management for key customers;
  • Implement and improve a customer-focused service management strategy including tools and processes, apply basic concepts of service management, software life cycle management, project and validation management;
  • Develop other people (peer education, training contribution, students development and thesis support);
  • Deliver the data foundation to PV and Clinical functions, external partners and authorities wherever the product risk/benefit profile must be assessed, and the assessment is derived from PV data, independent from whether a product is OTC or prescription, drug or device;
  • Put internal customers in the position to deliver rapid responses to regulatory authorities and customers on safety and process topics which maintains Bayer's reputation;
  • Avoid emerging safety issues by rapidly detecting observations via signal detection and management solutions, contribute to worldwide joined initiatives for improved patient safety and risk/benefit surveillance;
  • Support product development, indication extensions and restrictions by generating comprehensive risk/benefit analysis on clinical and post marketing data of all kinds including social media, patient support programs and observational non-study healthcare data as available, search for potential benefit reports which might trigger new indications and related cross-selling;
  • Support product plant production quality using AE data as an indicator for plant production quality and generating observations upon occurrence of quality limitations due to batches leaving the specified parameter range or counterfeit products being sold under the Bayer label;
  • Increase the efficiency of PV and development processes by generating a high data throughput while keeping costs under control during repetitive analysis of >3 Mio adverse event reports stored in the Bayer PV database and even more records being analyzed on foreign databases such as FDA AERS and WHO VigiBase;
  • Support company acquisitions during takeover of foreign PV data.

WHO YOU ARE


Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:


Required Qualifications:


  • Pharmacovigilance or Clinical experience OR Bachelor of Science, Master of Science, B.S RPH, RN HCP or Life Science degree with at least five years of Pharmacovigilance experience or clinical experience or relevant Bayer Pharmaceuticals AG experience;
  • Demonstrated ability to analyze and solve complex problems and new demands;
  • Demonstrated ability to lead project teams in an agile environment and to take responsibility for outcomes;
  • Experience in working with the Oracle Argus Safety tool suite, Aris G or other Pharmacovigilance tools;
  • Experience in implementing solutions in Oracle SQL, SAS, R;
  • Expertise in the principles of software development, quality management, process and service management;
  • Knowledge of and experience with MedDRA dictionary;
  • Understanding of the concepts of taxonomies, terminologies and ontologies in the relevant medical science context;
  • Knowledge of GxP principles and operational aspects of IT systems;
  • Customer orientation and partnership with internal customers as well as external and internal colleagues in a global team;
  • Excellent verbal and written English skills;
  • Ability to analyze and solve problems and to structure complex tasks.


Preferred Qualifications:


  • Experience working with Argus tool;
  • Additional experience in SAP HANA DB, Python, Spotfire, Crystal Reports, Business Objects;
  • Knowledge of and experience with WHO DD, ATC Codes, SNOMED.

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