Associate Director Signal Management

Job Description

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

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

on upstream and downstream processes is a plus.

interdependencies

Languages : Fluency in English. Knowledge of other languages desirable.

Requirements

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 management. in depth knowledge in Master Data Governance and Strategy Expertise in Data Quality Management knowledge in Data Integration and Architecture Change Management and Data Migration