Drug Safety Coordinator
About the role
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- Perform oversight and/or processing for all types of safety events, and other medically-related project information.
- Serve as pharmacovigilance (PV) lead for projects providing project management/project management support as designated.
- Serve as support to management in all aspects of departmental activities, including coordination of extra departmental tasks as needed
- Serve as technical expert with regard to all aspects of safety monitoring, per global regulations, (ieFDA, ICH, EMA)
- Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information
- 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.
- As a member of staff, the employee is expected to 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*.
- Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.
- Provide oversight of and/or review and process safety events (pre-marketing, post-marketing, device and drug) and/or other medically related information per assigned tasks and project specific procedures*
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
- Act as project manager for assigned projects, liaising with sponsor, and management of timelines and budgets, as appropriate*
- Coordinate and lead project teams as assigned
- Coordinate functional safety activities in support of project manager on assigned projects
- Provide in-depth technical expertise*
- Perform safety review of clinical and diagnostic data as part of case processing
- Generation of project specific procedures*
- Support development of post-marketing safety activities, such as PSMF, RMP and PBRER
- Support QPPV as required
- Support development of clinical trial activities, such as DSURs, 6-monthly line listings, by liaising with other ICON departments and/or other Sponsor vendors
- Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues such as safety systems support for line listings or other requests from Argus or other safety database
- Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate*
- Actively identify out of scope activities and process efficiency/improvement needs
- Review assigned contracts and coordinate contract amendments/change orders as required*
- Coordinate project team and Sponsor meetings (including Investigator meetings) and teleconferences as required
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• A minimum of 3 year pharmacovigilance experience, or other equivalent clinical or pharmaceutical experience
• Excellent computer skills (Microsoft Word, Excel, Outlook, Access) and advanced safety database proficiency
Application process
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