Drug safety Associate / Sr. Drug Safety Associate / EL

Drug Safety Associate E/L (Entry Level):

Responsibilities

• *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.
• *Collaborate and work closely in the team processing Safety Events (Clinical pre-marketing, post-marketing, device and drug and/or other medically related information per assigned project specific procedures)
• *Ensure all ICON, Client, and regulatory timeframes are met for the processing and reporting of safety information
• *Complete all departmental project activities accurately and in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors' processes
• Liaise with Clients, ICON project managers, investigational sites, Competent Authorities, local notified bodies, and third parties as necessary.
• Coordinate and present at meetings (project and department) as required.
• Participate in Business Development activities as requested.
• Perform other activities as identified and requested by management.
• Support QPPV(s) on assigned projects as required.
• Prepare for and attend audits and inspections as requested.
• Awareness of Adverse Events/Serious Adverse Events (SAEs) and ability to train others to recognize the required standard per ICH GxP guidelines, submit them to the client, and liaise with other cross functional groups within the agreed/stated timelines.
• Review medically related information; perform safety review of clinical and diagnostic data as part of safety processing or medical information enquiries.
• Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing
• Request follow-up and perform query management
• Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
• May provide in-depth technical expertise for key Safety Systems such as the Safety Database.
• Accountable for using relevant Safety tracking systems to maintain project files and data in an inspection ready state
• Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
• Attend internal, drug safety and project specific training sessions
• Create and maintain project specific working files, case report files and project central files

Drug Safety Associate:

Responsibilities

• *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.
• *Collaborate and work closely in the team processing Safety Events (Clinical pre-marketing, post-marketing, device and drug and/or other medically related information per assigned project specific procedures)
• *Ensure all ICON, Client, and regulatory timeframes are met for the processing and reporting of safety information
• *Complete all departmental project activities accurately and in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors' processes
• Liaise with Clients, ICON project managers, investigational sites, Competent Authorities, local notified bodies, and third parties as necessary.
• Coordinate and present at meetings (project and department) as required.
• Participate in Business Development activities as requested.
• Perform other activities as identified and requested by management.
• Support QPPV(s) on assigned projects as required.
• Prepare for and attend audits and inspections as requested.
• Awareness of Adverse Events/Serious Adverse Events (SAEs) and ability to train others to recognize the required standard per ICH GxP guidelines, submit them to the client, and liaise with other cross functional groups within the agreed/stated timelines.
• Review medically related information; perform safety review of clinical and diagnostic data as part of safety processing or medical information enquiries.
• Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing
• Request follow-up and perform query management
• Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
• May provide in-depth technical expertise for key Safety Systems such as the Safety Database.
• Accountable for using relevant Safety tracking systems to maintain project files and data in an inspection ready state
• Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
• Attend internal, drug safety and project specific training sessions
• Create and maintain project specific working files, case report files and project central files.
• In this position you may manage Clients or Project specific processes, associated with the entire medical information, adverse events process, and/or safety reporting processes: which may include safety data collected from clinical trials and/or post marketing setting for specified projects or act as safety lead for multiple smaller pharmacovigilance and/or standalone projects.
• May monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget and escalate to upper management as needed; and provide necessary data to support Change Notification Forms and/or Change Orders.

Senior Drug Safety Associate:

Responsibilities

• *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.
• *May serve as the main point of contact for the Client/Sponsor/Customer for the life cycle of assigned stand-alone projects and the main safety point of contact for assigned full-service projects.
• *May serve as the main contact or collaborate and work closely in the team processing Safety Events (Clinical pre-marketing, post-marketing, device and drug and/or other medically related information per assigned project specific procedures)
• *Awareness of Adverse Events/Serious Adverse Events (SAEs) and ability to train others to recognize the required standard per ICH GxP guidelines, submit them to the client, and liaise with other cross functional groups within the agreed/stated timelines.
• *Ensure all ICON, Client, and regulatory timeframes are met for the processing and reporting of safety information
• *Complete all departmental project activities accurately and in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors' processes
• Liaise with Clients, ICON project managers, investigational sites, Competent Authorities, local notified bodies, and third parties as necessary
• Oversee implementation of projects, including client communications, project-specific plans, system set-up, and establishment of appropriate and agreed-upon metrics.
• Coordinate and present at meetings (project and department) as required.
• Participate in Business Development activities as requested.
• Perform other activities as identified and requested by management.
• Support QPPV(s) on assigned projects as required.
• Prepare for and participate in audits and inspections as requested.
• Serve as technical expert with regard to all aspects of safety monitoring, per global regulations, (ie FDA, ICH, EMA)
• Responsible for preparation and execution of risk management activities and project mitigation plans as needed, in collaboration with other team members.
• Consistently contributes to solving technical and/or operational problems by proposing and executing innovative solutions, which influence program/project direction.
• Maintain updated network list of Named Safety Contacts/LQPPV
• Review medically related information; perform safety review of clinical and diagnostic data as part of safety processing or medical information enquiries.

  Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files

• May provide in-depth technical expertise for key Safety Systems such as the Safety Database.
• Accountable for using relevant Safety tracking systems to maintain project files and data in an inspection ready state
• *Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
• Completion of project status reports/review meetings, including burn hours, profit margins, quality review findings, and other metrics.
• *Lead identification of out-of-scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required.
• Participate in process improvement by actively identifying process improvements, developing better procedures, and implementing those change/process improvements.
• *Train/mentor other team members
• Coordination and participation in interdepartmental activities (e.g. quality control processes, quality assurance (audits), miscellaneous project activities).
• Travel (up to 5%) domestic and/or international.
• Prepare and deliver safety presentations at investigator meetings, client meetings, and internal meetings as appropriate.
• Provide project specific training to Clinical Operations/Project Management, Client and Investigators as required. Provide support and training in study specific aspects of case-handling, adverse event reporting and other tasks for team members of assigned projects.

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