Specialist, Pharmacovigilance

Description

• Lead and support the design, deployment, and continuous improvement of ICSR capabilities and tools, including automation, AI-based, and data-driven solutions.
• Collaborate with Case Management and cross-functional partners to ensure operational readiness, adoption, and compliant integration of new capabilities.
• Drive governance, training, and performance monitoring frameworks that keep capabilities reliable, effective, and inspection-ready.
• Apply pharmacovigilance expertise to evaluate data accuracy and process alignment
• Partner with system and process owners to identify gaps, propose corrective actions, and implement sustainable improvements.
• Support core case-management operations by providing input and validation for protocol-related or capability-linked activities, ensuring operational readiness and compliance.
• Design and execute structured case-testing scenarios, including the creation of realistic ICSR case scenarios, detailed test scripts, and validation steps to ensure accurate system behavior, data integrity, and alignment with end-to-end case management processes.

Behavioral Competencies

• Ability to work independently and proactively manage responsibilities in a remote, cross-regional environment.
• Strong problem-solving mindset, with the ability to understand issues, propose solutions, and escalate appropriately.
• Collaborative team spirit, with a genuine commitment to shared success, constructive communication, and respectful partnership with colleagues across sites and time zones.
• High professionalism, including reliability, accountability, and a consistent focus on quality and compliance.
• Positive, solution-oriented attitude, with the ability to navigate ambiguity and adapt to evolving priorities.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related discipline.
• 5–8 years of experience in pharmacovigilance, case management, or related regulated operations.
• Deep understanding of the ICSR lifecycle (intake, processing, reporting) and PV concepts (seriousness, causality, expectedness, MedDRA).
• Experience contributing to process improvement, AI or automation initiatives, or workflow optimization in a regulated environment.
• Experience designing, writing, and executing test scripts or case-testing scenarios to validate system functionality and data accuracy
• Strong analytical, communication, and collaboration skills.
• Fluency in English (written and spoken).