Signal Management - SME

Key Responsibilities & Requirements

1. Lead and contribute to Pharmacovigilance (PV) business and digital transformation initiatives, including process redesign and operating model optimization.
2. Develop future-state (To-Be) frameworks aligned with regulatory requirements and business objectives.
3. Drive end-to-end Signal Management, including signal identification, validation, prioritization, assessment, recommendations, and closure.
4. Apply quantitative and qualitative Signal Detection methodologies across multiple data sources and therapeutic areas.
5. Act as a Subject Matter Expert (SME) and advisor to internal teams and clients on Signal Management best practices.
6. Collaborate with product engineering teams to translate business requirements into functional and technical specifications.
7. Support automation, analytics, AI/ML-enabled Signal Detection solutions, including tool implementation and optimization.
8. Demonstrate hands-on experience with multiple Signal Detection platforms and interpretation of disproportionality metrics (PRR, ROR, EBGM) and trend analysis.
9. Participate in Signal Review Committees and cross-functional forums, providing scientific recommendations and expert guidance.

Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with 8–12 years of PV experience, particularly in Safety Signal Detection and Management. Strong analytical, scientific writing, and communication skills. Transformation, AI/ML, tool development/validation, and consulting/COE/client-facing experience preferred.