Data Manager Pharmacovigilance, Benefit Risk Mgmt
Your tasks and responsibilities
The primary responsibilities of this role, (Data Manager, Pharmacovigilance), are to:
- Conduct the primary, recurrent and further analyses to generate the data by providing data from the ARGUS database relating to reports and documents to be sent to the regulatory authorities (e.g. PBRER, DSUR,RMP), subject-specific inquiries from authorities, interaction between internal medical committees (e.g. the Global Safety Committee) and internal documents for approved products (e.g. Company Core Data Sheet), signal detection and signal management matters, activities relating to the weekly or product-specific ongoing monitoring and any data from clinical settings or other data sources, with emphasis on adverse event reporting databases;
- Strategize and align with the GSLs in developing data analysis strategies and in generating outputs using suitable Pharmacovigilance database retrieval strategies;
- Independently ordering and creating the required output formats;
- Independently generate data and analyses by creating overviews, summaries, preliminary selections and criteria searches;
- Format and edit data in line with the required conditions (sorting, filtering, and flagging);
- Perform calculations relating to frequencies, exposures and reporting rates. In alignment with the GSL, create, update and adjust work templates/workbooks (e.g. in DAVIS, Spotfire) or Full-Info Excel outputs for recurrent analyses for ongoing monitoring or aggregated reports;
- Create visualizations in the form of graphics and tables for regulatory reporting, internal safety updates, signal evaluations and other analysis purposes and product-specific matters;
- Generate the data including descriptive statistics, trend analysis, outliers and correlations, and provide a preliminary assessment of relevant data, as well as reviews of prior data and relevant comparisons;
- Advise the GSLs on database content by knowing data entry rules and policies and recommending suitable presentation formats;
- Advise senior management in the BRM organization on the use of tools, structure of queries (e.g. in accordance with MedDRA criteria, WHO Drug) and the best presentation formats for results data;
- Act as advanced trainer to GSLs on analytical tool use, database content and query strategies, as well as providing deep content expertise in creating enduring training materials.
- Establish and maintain libraries of items of interest linked to the database for output harmonization. Develop standardized solutions for recurring data analysis tasks across BRM groups;
- Responsible for the technical onboarding and initial training for new GSLs on the Pharmacovigilance BRM workflows by demonstrating important programs and tools, providing assistance with software and system access and other tool-related and process-oriented procedures;
- Contributing to problem solving in BRM processes by interfacing with Analytics, Pharmacovigilance Single Case Processing and any other Pharmacovigilance roles. Promoting cross-group standardization processes for activities within the therapeutic BRM groups. Holding structured information exchange sessions on specific topics to improve quality assurance;
- The partnership between the BRM-DA and the GSLs will further improve the speed and quality of data outputs from Pharmacovigilance databases, their interpretation, documentation and communication;
- The BRM organization will in this way have better insights into critical data and an enhanced foundation to perform medical assessments and evaluations, which are necessary to further develop the safety profile and risk-benefit assessment of Bayer products, and allows the GSLs to act more strategically;
- In the long-term, enhancing our data management capabilities through this position will save costs and increase efficiency;
- At the same time, this position contributes to standardizing procedures in BRM, which is expected to have a positive impact on the quality of results and improve regulatory inspection readiness;
- By interfacing with Pharmacovigilance Analytics, PV Single Case Processing and other Pharmacovigilance functions, there will be more information exchanged within and between the working groups, thereby increasing transparency.
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:
- Master’s degree in any discipline with at least 4 years of relevant experience is required;
- Demonstrated Ability to analyze and solve complex problems and new demands;
- Experience and confidence in working with databases and data analysis tools (e.g. Spotfire, Excel); Good understanding of retrieval processes and knowledge of database query language for generating outputs (e.g. SQL).
- Strong technical expertise in managing tools, data queries and data processing are required;
- Demonstrated ability to learn new data bases and data analysis tools (e.g. DAVIS, Empiri-ca) and retrieval tools that access this database;
- Ability to analyze problems and contribute to developing solutions for these;
- Good communication and presentation skills for organized information exchange on specific topics between the various working groups;
- Project management skills
- Very good written and spoken knowledge of English.
- Bachelor’s or Master’s degree in Information Systems or computer science preferred.
- Professional experience in a field of natural sciences, such as medicine/human biology/pharmaceuticals or medical information/ documentation management strongly preferred;
- Experience in pharmacovigilance strongly preferred;
- Good understanding of technology landscape and data pipeline as well as experience in de-fining technical requirements for business and an understanding of the use and consumption of data are strongly preferred.
- Knowledge of the activities and
processes involved in pharmacovigilance and the rules and
regulations associated with this (GxP guidelines), as well as
knowledge of periodic safety reporting (e.g. PBRER, DSUR) to the
responsible supervisory authorities (e.g. EMA, FDA) and knowledge
of medical classification systems (e.g. MedDRA coding) are strongly
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Functional Area: [sap_fa_30]
Entry Level: 5