The position holder is responsible for
establishing appropriate procedures and conventions for
activities and processes to support data retrieval and data
analysis from Global Drug Safety databases in close
collaboration with the internal or external customer. He is
responsible to ensure appropriate delivery of safety data to
support the analysis and safety-based decision making for Merck
Serono medicinal products. As key user of the data warehouse
and database reports he actively provides user requirements and
participates in various GDS IT projects, as relevant.
Define, implement and maintain an
effective query process and tracking tool, to ensure that all
database outputs requested for periodic reports
(PSURs/PBRERs, DSURs, pSUSARs etc), and any other data
queries (narratives, authority requests, requests for
internal audits or regulatory authority inspections, signal
detection/evaluation, Health Authority Safety-related
Queries, and all other ad hoc requests) are delivered in time
Implement and maintain a quality control
process for all database queries.
Manage the delivery of responses to
database queries so that requests are in line with the
customer expectations, prioritized effectively, with an
appropriate level of urgency, and the ability to accommodate
the variability in demand.
Manage the delivery of data outputs with
adequate expertise in data retrieval and display including
the collaboration with external vendors and consultants as
Ensure knowledge and compliance with
worldwide pharmacovigilance regulations, guidelines and
Ensure the creation of technical
documentation and user guides describing the tools and search
Provide user support and proactively
collect user feedback to improve the process and tools
Responsible to formulate and communicate
business requirements in the scope of development of new
Standard Reports and tools to be used.
Manage development of new reports,
together with colleagues from the GDS Systems group.
Educated to university degree level with a
scientific degree with a strong affinity to IT, e.g. medical
Minimum 5 years experience in querying
relational databases using structured query language (SQL)
and excellent knowledge of Oracle databases.
Minimum 2 years experience in the
Pharmaceutical industry , best in Drug Safety or Regulatory
Affairs – excellent understanding of business requirements
for periodic safety reports, signal detection and safety
Proven experience of the retrieval,
analysis, display and output designs of clinical and / or
drug safety data.
Familiarity with Good Clinical Practice
and global regulatory requirements relevant to functioning
and validation of Drug Safety databases and electronic
Knowledge of data warehouse architectures
and principles as well as Business Intelligence tools (such
as IBM Cognos and SAP Business Objects) would be an
JOB-SPECIFIC COMPETENCIES &
Rigorous and well-organised.
Good team-working skills.
Project management skills.
Proficient computer skills, eg word
processing, presentation development, spreadsheets, database
Will to learn continuously and to propose
Proficiency in prioritizing assignments
and ability to adapt rapidly to changing priorities.
Good knowledge of business regulations and
Excellent written and verbal communication
Fluent in written and spoken English, a
second language is an asset.