Central Operations Specialist (PV, Pharmacovigilance)

Central Operations Specialist

As a Central Operations Specialist in Patient Safety Operations, you will play a pivotal role in the efficient, high-quality, and compliant delivery of safety data outputs. You will process and report Individual Case Safety Reports (ICSRs) and device safety reports while collaborating with global vendors and cross-functional teams to drive continuous improvement and inspection readiness.

Responsibilities

• Oversee safety data quality by monitoring workload, compliance, and performance standards.
• Manage vendor and process collaboration to ensure effective ICSR and medical device safety activities.
• Drive continuous improvement by developing and reviewing metrics and KPIs.
• Lead AI and innovation initiatives, including the implementation of AI-augmented activities.
• Provide governance and subject matter expertise for case processing and issue escalations.
• Support regulatory reporting projects by preparing documentation and ensuring quality standards.

Requirements

• Minimum of 2 years of relevant experience in the pharmaceutical industry, preferably in pharmacovigilance.
• Strong working knowledge of global pharmacovigilance regulatory obligations and compliance standards.
• Proven project and conflict management skills with the ability to solve problems effectively.
• Agile mindset with experience working in matrix environments and leading squads.
• Degree-level qualification in a scientific or relevant field.