IT Director coordinating design and optimization of OpenShift platform at USAA. Driving strategic direction, risk management, and vendor oversight in technology support functions.
About the role
- Support the integration of local signal detection and management requirements into the global process
- Define and oversees the long-term strategy to ensure that Sandoz maintains its world class leading position in automated signal detection and evaluation.
- Lead and manage a team of external service providers who are accountable for detecting and analyzing technical signals from post-marketing surveillance in the signal management tool for all Sandoz products, Sandoz group companies or Sandoz partners (for which an agreement is in place) where Sandoz is the global safety database holder.
- Oversee and ensure maintenance of all Sandoz MedDRA Queries which are used by Patient Safety
- Drive the development and implementation of efficient workflow processes for the Safety Management Team (SMT).
- Provide strategic leadership and oversight for all signal detection and management activities conducted by the ESP, leveraging internal and external databases.
- Ensure that all new relevant medical safety signals originating from signal review or analyses from external Health Authority databases are adequately communicated to the respective Safety Lead for further escalation to the SMT.
- Partner with Safety Leads who present safety signals to various internal and external boards
- Review of Safety Signal sections of License partner agreements. Ensure timely and accurate communications of signals to license partners as per PVA and to PS countries.
- Support the development and customization of signal detection and management software so to contribute to it is compliance with all applicable regulatory requirements.
- Develop new approaches (including policy, methodology, process improvements) for signal detection in Safety Signal software.
- Provide expert guidance in the development of all relevant aspects of signal detection strategy using post-marketing safety databases.
- Ensure the signal management tools support the required KPIs for signal detection and management
- Have an overall understanding of the processes and software related to signal management so to ensure processes related to signal management are interconnected and streamlined as per lean principles.
- Develop metrics for and ensure compliance with business rules of signal review and provide a periodic compliance report to Patient Safety leadership.
- Represent Sandoz on external working groups related to Safety Signal Management.
- Lead talent-pipeline, onboarding, training and mentoring activities for new members.
- Lead audits and inspections as a SME for Safety Signal Management.
Requirements
- At least 6 years’ experience in pharmacovigilance operations, including some hands-on experience in performing signal detection and management.
- Additional hands-on experience in the preparation of aggregate reports, case processing, and risk management plans is a plus.
- Excellent understanding ICH GCP, GVP guidelines, local pharmacovigilance regulations and medical terminology
- Excellent understanding of signal detection process; understanding on upstream and downstream processes is a plus.
- Attention to detail, quality focused and ability to identify process interdependencies
- Strong organizational and project management skills
- Ability to operate effectively in an international and matrix environment.
- Understanding of signal detection statistical methodology
- Excellent communication (written and verbal) and presentation skills
- Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with and development of safety databases/applications/software.
- Experience with PV audits and inspections and writing and implementation of CAPA
- Problem solving and strong negotiation and conflict management skills.
- Fluency in English.
- Knowledge of other languages desirable.
Benefits
- 30 days of annual leave
- Holiday allowance
- Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
- Company pension schemes and capital formation benefits
- Parental leave
- Other offerings, such as bike leasing
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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