The Patient Safety Associate II supports global pharmacovigilance activities across clinical trials and post-marketed projects, executing safety processes under supervision. Responsibilities may include case processing, regulatory submissions, literature surveillance, affiliate coordination, and safety intelligence, depending on project needs. The Associate follows international and local regulations, internal procedures, and quality standards, while working collaboratively within cross-functional teams to deliver safety deliverables.
Key Accountabilities:
General
Develop knowledge of safety profiles, labeling, and global regulations
Follow project-specific procedures and workflows
Support compliance with regulatory reporting timelines
Assist with audit and inspection preparation as directed
Review basic metrics and participate in improvement initiatives
Identify potential issues and report to supervisors
Follow documentation and archiving procedures
Participate in training and process implementation
Support client interactions under supervision
Work with team members on safety deliverables
Support recent team members as needed
ICSR processing
Monitor incoming reports from various sources (mailboxes, EudraVigilance, literature)
Follow established safety procedure implementation
Perform data entry of valid cases into safety databases
Validate the accuracy of expectedness, causality assessment, and seriousness criteria for reported events, Execute basic ICSR processing workflows under supervision
Prepare case documentation including narratives
Ensure MedDRA coding according to standards
Support generation of routine safety reports and listings
Initiate translation requests when required. Review source documents for medical consistency and cohesiveness.
Conduct quality and validation checks to ensure accuracy.
Request follow-up and perform query management as applicable
Follow compliance activities and assist with metrics coll