Description

You will ensure local safety activities comply with regulations and company policies, manage case quality and regulatory submissions, and maintain key performance indicators for a global CRO's client.

Requirements

• Subject matter expert in case management activities
• Ability to oversee training of local employees and business partners
• Skills in regulatory monitoring for impact on vigilance activities
• Proficiency in maintaining KPIs and presenting in team meetings
• Knowledge of local literature article identification for AE reporting

Responsibilities

• Perform quality checks of PV cases and ensure proper English translation
• Maintain local tracker of individual safety reports
• Monitor regulatory timelines for safety report submissions to local health authorities
• Establish and maintain local compliance indicators for safety report submissions
• Perform reconciliation with distributors, third parties, vendors, and internal stakeholders