Product Safety Coordinator

Overview

• Coordinate receipt and triage of adverse event reports for marketed and investigational products from multiple sources.
• Perform preliminary evaluation of clinical trial, post-marketing, and solicited adverse event reports.
• Ensure completeness and accuracy of adverse event reports through communication with partners and affiliates.
• Prepare cases including duplicate searches, initial data entry, and assignment to specialists.
• Determine seriousness, expectedness, and validity of adverse event cases.
• Prioritize workload to meet company and regulatory authority deadlines effectively.
• Distribute information internally and externally to partners, affiliates, and other stakeholders.
• Work remotely, adhering to a Monday-Friday schedule with 7.5 hours per day.

Key Responsibilities & Duties

• Manage receipt and triage of adverse event reports from various sources.
• Conduct preliminary evaluations of clinical trial and post-marketing adverse event reports.
• Communicate with affiliates to verify report accuracy and completeness.
• Prepare cases by performing duplicate searches and assigning cases to specialists.
• Ensure regulatory compliance by prioritizing workload and meeting deadlines.
• Distribute adverse event information to relevant stakeholders as required.
• Collaborate with team members to ensure efficient case management.
• Maintain accurate records and documentation within database systems.

Job Requirements

• Bachelor’s degree in a scientific or medical discipline is required.
• Minimum of 3 years of experience in product safety or pharmacovigilance.
• Proficiency in data coding and retrieval using database technology.
• Strong knowledge of medical terminology and regulatory requirements.
• Exceptional attention to detail and ability to multitask effectively.
• Excellent written and verbal communication skills.
• Ability to work independently as well as collaboratively within a team.
• Familiarity with adverse event reporting processes and standards.