Associate Director Signal Management
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Job Location:
Basel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Purpose
As the process owner for Signal Management the Associate Director Global Signal Management is responsible for managing and leading a team of external partners who identifies and analyzes all safety signals in the Safety Signal management tool for all products and products from partners for which an agreement is in place.
Ensures compliance and efficiency of Safety Signal Management activities for our products.
Responsible for Safety Training for all employees and acting as subject matter expert for MedDRA queries
Support the development customization and maintenance of the signal management tool to ensure it supports all signal detection and management activities in an efficient and effective way.
As the global process and business owner for Signal Management has to:
1. Support the integration of local signal detection and management requirements into the
global process
2. Define and oversees the long-term strategy to ensure that it maintains its world class leading position in automated signal detection and evaluation.
3. 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 products our group companies or our partners (for which an agreement is in place) where the global safety database holder.
4. Oversee and ensure maintenance of all our MedDRA Queries which are used by Patient Safety
5. Drive the development and implementation of efficient workflow processes for the Safety Management Team (SMT). This includes the timely update of Business Guidance Documents and SOPs accordingly.
6. Provide strategic leadership and oversight for all signal detection and management activities conducted by the ESP leveraging internal and external databases. Ensure practices are aligned with regulatory guidance and industry standards while continuously tailoring signal management processes according to the risk profile of the product portfolio. Proactively monitor the evolving regulatory landscape to maintain compliance and drive innovation in signal management.
7. 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.
8. Partner with Safety Leads who present safety signals to various internal and external boards
9. Review of Safety Signal sections of License partner agreements.
10. Ensure timely and accurate communications of signals to license partners as per PVA and to PS countries.
11. Support the development and customization of signal detection and management software so to contribute to it is compliance with all applicable regulatory requirements. If required contribute to linking the tool with appropriate regulatory information so that its outputs can be used for downstream activities (e.g. addendum to clinical overview presentations at Signal Review Team (SRT) SMT Medical Safety Review Board (MSRB) and our Porfolio Stewardship Board (SPSB) meetings aggregate reports).
12. Develop new approaches (including policy methodology process improvements) for signal detection in Safety Signal software. Contribute to the development and customization of the tool having in mind how it can be used to integrate AI solutions in the signal management process.
13. Provide expert guidance in the development of all relevant aspects of signal detection strategy using post-marketing safety databases.
14. Ensure the signal management tools support the required KPIs for signal detection and management
15. 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.
16. Develop metrics for and ensure compliance with business rules of signal review and provide a periodic compliance report to Patient Safety leadership.
17. Represent us on external working groups related to Safety Signal Management.
18. Lead talent-pipeline onboarding training and mentoring activities for new members.
19. Lead audits and inspections as a SME for Safety Signal Management
As the process owner for Signal Management the Associate Director Global Signal Management is responsible for managing and leading a team of external partners who identifies and analyzes all safety signals in the Safety Signal management tool for all products and products from partners for which an agreement is in place.
Ensures compliance and efficiency of Safety Signal Management activities for our products.
Responsible for Safety Training for all employees and acting as subject matter expert for MedDRA queries
Support the development customization and maintenance of the signal management tool to ensure it supports all signal detection and management activities in an efficient and effective way.
As the global process and business owner for Signal Management has to:
1. Support the integration of local signal detection and management requirements into the
global process
2. Define and oversees the long-term strategy to ensure that it maintains its world class leading position in automated signal detection and evaluation.
3. 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 products our group companies or our partners (for which an agreement is in place) where the global safety database holder.
4. Oversee and ensure maintenance of all our MedDRA Queries which are used by Patient Safety
5. Drive the development and implementation of efficient workflow processes for the Safety Management Team (SMT). This includes the timely update of Business Guidance Documents and SOPs accordingly.
6. Provide strategic leadership and oversight for all signal detection and management activities conducted by the ESP leveraging internal and external databases. Ensure practices are aligned with regulatory guidance and industry standards while continuously tailoring signal management processes according to the risk profile of the product portfolio. Proactively monitor the evolving regulatory landscape to maintain compliance and drive innovation in signal management.
7. 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.
8. Partner with Safety Leads who present safety signals to various internal and external boards
9. Review of Safety Signal sections of License partner agreements.
10. Ensure timely and accurate communications of signals to license partners as per PVA and to PS countries.
11. Support the development and customization of signal detection and management software so to contribute to it is compliance with all applicable regulatory requirements. If required contribute to linking the tool with appropriate regulatory information so that its outputs can be used for downstream activities (e.g. addendum to clinical overview presentations at Signal Review Team (SRT) SMT Medical Safety Review Board (MSRB) and our Porfolio Stewardship Board (SPSB) meetings aggregate reports).
12. Develop new approaches (including policy methodology process improvements) for signal detection in Safety Signal software. Contribute to the development and customization of the tool having in mind how it can be used to integrate AI solutions in the signal management process.
13. Provide expert guidance in the development of all relevant aspects of signal detection strategy using post-marketing safety databases.
14. Ensure the signal management tools support the required KPIs for signal detection and management
15. 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.
16. Develop metrics for and ensure compliance with business rules of signal review and provide a periodic compliance report to Patient Safety leadership.
17. Represent us on external working groups related to Safety Signal Management.
18. Lead talent-pipeline onboarding training and mentoring activities for new members.
19. Lead audits and inspections as a SME for Safety Signal Management
Requirements
Ideal Background
Education: Bachelor of Science in Pharmacy /Bachelor of Science in Nursing /
PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required.
Experience and Skills:
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 motivate direct and foster teamwork strong negotiation and conflict management.
Ability to develop and maintain effective working relationships with superiors and peers.
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.
Ability to work independently under pressure demonstrating initiative and flexibility through effective innovative leadership ability.
Experience with PV audits and inspections and writing and implementation of CAPA
Problem solving and strong negotiation and conflict management skills.
Some understanding of how large language models work knowledge of regulations on the use of AI in healthcare and more specifically in pharmacovigilance (e.g. CIOMS XIV EU AI act).
Languages: Fluency in English. Knowledge of other languages desirable.
Required Skills:
Responsible for overseeing the strategy governance and quality of all master data (Vendors Customers Materials) ensuring its accuracy consistency and alignment with business processes across the organization. Requirements: 10 years of experience in global data depth knowledge in Master Data Governance and Strategy Expertise in Data Quality Management knowledge in Data Integration and Architecture Change Management and Data Migration
Company Industry
IT Services and IT Consulting
Key Skills
- Portfolio Management
- Wealth Management
- Financial Services
- Hybris
- Microsoft Word
- Banking
- Cash Management
- Data Management
- Microsoft Powerpoint
- Securities Law
- Microsoft Excel
- Internet Of Things
