The Product Safety Surveillance Branch (PSSB) coordinates, develops, implements and maintains safety surveillance program for TSG products to be in compliance with FDA/ICH, Army/DOD regulations. The safety surveillance program is systematic approach, documented in a strategy recommendation report or safety surveillance plan and briefed to the appropriate personnel. The safety surveillance program includes a process for reviewing, evaluating, and managing accumulating data on adverse events (AEs) from the entire clinical trial database. The details of what AEs specifically and the frequency of the reviews will be determined as outlined by the program for each program.
Personnel performing in this task area shall have the capability of utilizing strong communication and conflict resolution sills. Additionally, personnel performing in this task area shall have the ability to apply demonstrated knowledge and use of FDA validated systems and associated processes, as they pertain to safety pharmacovigilance databases.
- Assist PSSB in the development and implementation of clinical safety and pharmacovigilance standards, processes, templates and forms e.g., format and content of narrative descriptions, medical assessment and reporting requirements for SAEs to use in support of clinical safety reviews, etc. as required.
- Assist in assessment of SAE reports which may include data entry and preparation of SAE narratives, as directed by or Standing Operating Procedures (SOP) format, and coding of event terms in safety database utilizing the Medical Dictionary for Regulatory Activities (MedDRA) dictionary and concomitant medications using WHODrug.
- Monitor the safety mailbox 7 days a week. Monitor the mailbox for new incoming unexpected and related SAEs once each day over the weekend or on holidays. If an expedited SAE is identified over the weekend or on a holiday, the Contractor shall begin the case processing process per USAMMDA SOPs.
- Triage safety reports for regulatory reporting purposes (e.g. expedited report), interpret clinical data, perform regulatory evaluation and assign causality by obtaining the safety physicians input; define, initiate and track follow-up information /correspondence with clinical site staff, and IPT representatives, as required, through to case closure; ensure entry of SAEs into real-time safety database (Argus); prepare safety reports according to specified regulatory guidelines; and facilitate communication with clinical, regulatory and data management/biostatistics, the product manager, and other IPT members for individual clinical trial SAE reports, as required. regulatory and data management/biostatistics, the product manager, and other IPT members for individual clinical trial SAE reports, as required.
- Assist with monitoring deliverables to and from partners, as outlined in safety data exchange agreements, or other applicable agreements (e.g., partners may require safety reports for their regulatory authorities), as required.
- Participate as a consultant on IPTs, providing guidance and input and/or drafting and reviewing safety sections of clinical protocols, investigator’s brochures, Data Monitoring Committee (DMC) or Data Safety MoniProvide support to IPTs, IPT working groups (WG), clinical study teams, investigative sites, and external customers, and partners regarding product safety issues.
- Provide support to IPTs, IPT working groups (WG), clinical study teams, investigative sites, and external customers, and partners regarding product safety issues.
- Participate in developing standard output formats for standard tables and listings of safety data for annual reports, data reconciliation, safety committee reviews and final clinical study reports.
- Draft and or review safety related meeting minutes and prepare agendas for safety related meetings. The Contractor shall develop and present general safety training to clinical sites, as required. The Contractor shall ensure a complete safety section of the trial master file is documented at the end of a clinical trial.
- Work closely with data management to reconcile the clinical database with the safety database and provide narrative information to regulatory affairs for reporting to the FDA.
- Assist in drafting data entry user guidelines and updating existing data entry user guidelines for the safety database.
- Prior to the start of a clinical trial the Contractor shall review an unblinding plan for TSG-sponsored blinded clinical trials. The unblinding plan shall include procedures for the following:
- unblinding a study subject in an emergency situation,
- managing accidental unblinding,
- unblinding data for the purpose of notification to DMC,
- unblinding data for analysis purposes at a pre-planned point during the trial (i.e., formal interim analysis of safety and/or efficacy) and/or at the end of the trial (i.e., the final analyses for safety and efficacy that are presented in the tables, listing and figures), and
- Unblinding for IND safety reports submitted to FDA.
Have the capability of utilizing strong communication and conflict resolution sills.
Have the ability to apply demonstrated knowledge and use of FDA validated systems and associated processes, as they pertain to safety pharmacovigilance databases.
Candidates for positions under ICON Government and Public Health Solutions contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
- Must be a US Citizen
- 3 year(s): Experience in clinical safety surveillance
- Possess demonstrated knowledge of FDA and ICH Standards, including 21 CFR Part 312 and use of validate systems and associated processes.
- Knowledge of safety database Argus.
- Strong communication and resolution skills.
- Bachelors or better
- Leader: Inspires teammates to follow them
- Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well
- Dedicated: Devoted to a task or purpose with loyalty or integrity
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
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