• Bayer
  • $106,390.00 -159,250.00/year*
  • Whippany , NJ
  • Information Technology
  • Full-Time

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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life.

At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Apply online

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

+ Independently ordering and creating the
required output formats;

+ Independently generate data and analyses by
creating overviews, summaries, preliminary selections and criteria

+ Format and edit data in line with the
required conditions (sorting, filtering, and

+ 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

+ 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

+ 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

+ 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

+ 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

+ 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

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


+ Master's degree in any discipline
with at least 4 years of relevant experience is

+ Demonstrated Ability to analyze and
solve complex problems and new

+ 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.

+ Strong technical expertise in managing
tools, data queries and data processing are

+ 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

+ Good communication and presentation
skills for organized information exchange on specific topics
between the various working

+ Project management

+ Very good written and spoken knowledge
of English.


+ Bachelor's or Master's
degree in Information Systems or computer science

+ Professional experience in a field of
natural sciences, such as medicine/human biology/pharmaceuticals or
medical information/ documentation management strongly

+ 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

+ 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

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the \"Passion to Innovate\" and the \"Power to Change\", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

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.

Country:United States


Functional Area:[sap_fa_30]

Entry Level:5
Associated topics: data analytic, data center, data quality, data warehouse, data warehousing, database, etl, erp, hbase, teradata

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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