Drug Safety Associate

* Prepare, perform quality checks of, and submit expedited and periodic reports for all types of safety events, and other medically-related project information under mentorship of a Senior Drug Safety Associate or above.
* Prepare, perform quality checks of, global pharmacovigilance intelligence requirements under mentorship of a Senior Drug Safety Associate or above.
* Serves as safety reporting lead for multiple smaller projects and/or pharmacovigilance intelligence lead for pharmacovigilance intelligence stand-alone projects.
* Ensure all ICON and/or Sponsor timeframes are met for the reporting of safety information and for the release of global pharmacovigilance intelligence requirements.
* Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.

• Recognize, exemplify, and adhere to ICON's values, which center around our commitment to People, Clients, and Performance.
• Embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 10%) domestic and/or international as required.
• Complete all departmental project activities accurately and in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors' processes.
• Prepare and perform quality checks of regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and third parties as applicable.
• Prepare and perform quality checks of global pharmacovigilance intelligence requirements and coordinate the timely completion of requirements for Health Authorities, Ethic Committees, Principal Investigators and third parties as applicable.
• Ensure compliance with source documentation for regulatory reporting requirements for safety reporting (pre-marketing, post-marketing, device and drug) and/or other pharmacovigilance requirements per assigned tasks and project specific procedures.
• Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information and/or the release of global pharmacovigilance intelligence requirements.
• Ensure the completion of all departmental project activities accurately and in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors.
• Provide input to and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.
• Liaise with Sponsors, ICON project managers, investigational sites, Competent Authorities, local notified bodies, and third parties as necessary.
• Attend project team meetings and teleconferences as required.
• Ensure files are in inspection ready state at all times. Prepare for and attend audits and inspections.
• Attends and assists training on regulatory reporting activities and/or pharmacovigilance intelligence requirements for Safety Reporting Group, project team, and other departments.
• Assist with generation of project specific procedures.
• Act as safety reporting lead for multiple smaller and/or pharmacovigilance intelligence standalone projects.
• Assist with identifying out of scope activities in conjunction with the Senior Safety Reporting Specialist or above (as applicable).
• Alert Line Manager to any quality or timeline issues. Share ideas and suggestions with team members, ensuring effective communication.
• Perform other activities as identified and requested by management.