Coordinator, Pharmacovigilance and Compliance

Role Summary

This position is responsible for procedure maintenance and training deployment of the Pharmacovigilance, Strategic Operations and Epidemiology Quality System. It participates in evaluating the AbbVie Quality System to enable training that ensures the right training, at the right time, for the right roles. This hybrid role is based on-site at AbbVie Lake County, IL.

Responsibilities

• Liaise with management and abject matter experts to oversee training to, awareness of and compliance with global regulatory requirements and organizational objectives
• Subject matter expert on the formatting and maintenance for controlled procedural documents
• Facilitates development and management of training materials associated with the Annual Adverse Event training
• Responsible for identifying and tracking the training needs for third party vendors to ensure awareness of compliance with organizational objectives and global legal and regulatory requirements
• Maintains training processes and relevant materials up to date
• Authors compliance documents
• Reviews, evaluates, and proposes necessary changes to regulatory documents
• Evaluates and develops appropriate work tools and methodologies to enable staff to continually improve performance and productivity.
• Determine appropriate documentation of training and related metrics as necessary.
• Facilitates communication related to training/meeting events in both electronic and printed mediums.
• Assists Training Directors/Managers, Business Process Owners and Business Subject Matter Experts in the coordination of course development and deployment to meet business and compliance requirements.
• Manages, maintains and updates electronic document repositories, training management systems
• Facilitate and coordinate materials for education of the QMS at AbbVie
• Develops and maintains positive professional relationships with vendors, internal customers, colleagues, etc. through excellent written and verbal communications.

Qualifications

• 3+ years supporting training development and delivery within the healthcare industry.
• Direct experience in Training, PV Training, documentation control on a global setting preferred
• Experience with US and global Pharmacovigilance regulations is preferred
• 5+ years direct experience with training coordination, preferably in a regulated environment.

Education

• High school diploma or equivalent. Some college preferred.