Head of Global Drug Safety Systems - (17000082) Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of
Johnson & Johnson, is recruiting for Head of Global Drug Safety Systems. As part of the Janssen Pharmaceutical
Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and
better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the
most promising science. We collaborate with the world for the health of everyone in it. Actelion is a leader in the
field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from
WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications. Job Responsibilities The
resource will work in a team oriented environment and will ensure that all computerized systems used by Global Drug
Safety (GDS) for pharmacovigilance purposes will be compliant on international regulations standards and follow all
internal good pharmacovigilance practices. The resource will also be responsible for planning strategically GDS system
needs, including recruitment and training of groups personnel and system improvement. The resource will:
- Supervise & coordinate Global Drug Safety Systems (GDSS) group activities and meetings.
- Be System Owner for the Drug Safety systems and the associated devices.
- Supervise System manager activities in administration, lifecycle, implementation, validation, support of the Drug
Safety Computerized Systems.
- Guarantee the qualification of GDS workstations.
- Supervise the Drug Safety Change Control processing.
- Supervise the related documentation for the computerized system management and approve validation activities.
- Lead project goals & objectives and contribute to project risks identification.
- Ensure cooperation with Business Partners in order to optimize collaboration, knowledge transfer and deliverables.
- Manage contracts with External Service Provider in relation with GDS systems.
- Provide an escalation point of contact for system deliverables.
- Contribute to inspection readiness GDS system documentation.
- Manage a team of people by promoting a framework encouraging employee contribution through goal setting, continuous
feedback and performance evaluation and development.
As part of his/her responsibilities related to the Electronic Submission Report System (associated to Argus) the
- Supervise the development, testing, user acceptance, compliance regulation of the electronic submission cases
- Evaluate with relevant persons (in EU and US) all new regulation which could impact the electronic ICSR submission
(with European Members States and EMA and with the FDA).
As part of his/her responsibilities in Business Intelligence Reports in Global Drug Safety the resource will:
- Supervise strategy & validation of all outputs for medical analysis, compliance and capacity management in
collaboration with GDS programmer experts.
As part of his/her responsibilities in Risk Management/Signal Detection the resource will:
- Supervise Business Impact Analysis activities in direct relation with the GDS Business continuity plan.
- Collaborate with relevant stakeholders in the elaboration of the PSMF (i.e system section D).
- Participate in the evaluation of signal detection tools (statistical methods, safety signal management).
Additionally, as part of Inter-departmental activities, the resource will:
- Liaise with Corporate IT departments for Operating system, Hardware, applications monitoring, and architecture
- Supervise IT Service Level Agreement contracted between Corporate IT, GDS and GDSS.
- Liaise with Head of CD Systems for all cross functional projects within Clinical development, data integration,
systems disaster recovery, business continuity management and GCD systems strategy.
- Liaise with GDS and Global Quality Management for the implementation of the Business Continuity Plan for GDS.
Including a complete system contingency analysis.
- Represent GDS during internal and external audits related to safety computerized systems in association with the GQM
- Represent GDS during inspections of safety computerized systems mandated by Health Authorities.
- Minimum 10 years of experience with management of Information Technology within Pharmaceuticals Industry, ideally in
- Extensive experience in software development, system life cycle management, IT strategy and computer systems
validation in clinical/pharmaceutical areas.
- Extensive understanding of drug safety business processes and use of IT solution to achieve process improvement.
- Good experience in information systems administration including drug safety databases, document management systems,
data warehousing, data management (standards coding thesauri, drugs dictionary) and ICSR source information collection
- Good Knowledge of international pharmacovigilance regulation (EU clinical trials directives, Volume 9A, US Code of
Federal Regulations and ICH Guidelines).
- Strong working knowledge in Quality Insurance for regulated computerized systems (FDA 21 CFR part 11, GxP, ICH
guidelines, EU directives & guidelines, ITIL, GAMP, ISO).
- Excellent organizational and problem solving skills, interpersonal skills, and the ability to work under pressure
and meet tight timelines.
- Fluency in English, both written and verbal.
- Good communicating and influencing skills.
- Degree preferably either in Computer Science or in Life Science, combined with relevant experience in the missing
If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your
: Drug Safety
: Sep 12, 2017