Safety Associate III

This job requires a person to be highly customer focused with excellent computer skills, including proficiency with MS Office. This position requires organizational skills with a high attention for detail, the ability to work in a team environment, meet deadlines, and prioritize. Excellent verbal and written communication skills are essential. Successful team member will support the Safety Services team, Clinical Operations project teams, and the Data Management team for the management of ongoing clinical studies and Pharmacovigilance-only projects.


  • Departmental Infrastructure
    • Actively works to promote operational excellence by monitoring and improving processes related to management of Individual Safety Case Reports (ICSRs), Clinical Events Committees (CECs), and Data Monitoring Committees (DMCs)
    • Provides content for the ongoing development and maintenance of Standard Operating Procedures and training materials for Safety Services department
    • Independently establishes work priorities at least daily with minimal input from Management
    • Maintains tracking tools for departmental key performance/quality indicator metrics
    • Meets key performance indicators and quality targets established by Head of Safety Services
    • Attends study team meetings and company staff meetings
    • Prepares aggregate Safety reports and submits to Regulatory Authorities
    • Performs any additional related work as required and assigned by Head of Safety Services
    • Assists Safety Services in quality assurance activities including audits, development of templates and guidelines
    • Develops and maintains knowledge of: global clinical trial Good Vigilance Practices for medical devices, pharmaceuticals, biologics, and combination products; Safety Services best writing practices and data entry conventions
  • Individual Safety Case Reports (ICSRs)
    • Set up and maintenance of project-related electronic and/or paper files for clinical study Trial Master File inclusion
    • Co-Authors study-specific Safety Management Plans based on clinical study protocol details and study budgeted safety services. Serves as Subject Matter Expert on regulatory requirements for global adverse event handling/reporting requirements
    • Reviews and tracks incoming ICSRs for completeness and clarity; submits site query requests to Data Management and/or investigative sites. Reviews investigational product literature for event expectedness/listedness for triage determination
    • Distributes notification of ICSR to Sponsor and Clinical Operations team, including case triage and regulatory submission requirements/deadline
    • Performs complete data entry of ICSRs into tracking system, regulatory report, and/or Safety database. Writes ICSR narratives. Interprets reported event information, including medical conditions, laboratory results, and medical procedures. Correctly determines relevant follow-up data required for ICSR completion
    • Organizes personal workload to ensure compliance with project-specific timelines and global reporting requirements for ICSRs
    • Performs quality check of peer ICSRs to ensure adherence to SOPs and study requirements (if applicable)
    • Submits ICSRs to regulatory agencies
    • Distributes Sponsor partner cross reports and expedited safety reports to investigator staff
    • Works with Sponsor or in-house Data Management teams to reconcile event information between Safety database and Clinical Database
    • Maintains solid knowledge of assigned study protocols for study-specific adverse event definitions, handling, and reporting requirements
  • Clinical Events Committee (CEC)
    • Acts as a CEC Coordinator. Co-authors CEC charter with Head of Safety or Co-CEC Coordinator. Gathers CEC member documents, tracks events for adjudication, prepares adjudication document packages including narratives. Quality checks documents prior to event adjudication.
    • Provides routine status updates to Sponsors and CEC members on the progress to complete event adjudication for studies.
    • Hosts CEC organizational meetings and event adjudication meetings. Generates meeting agendas and highlights. Enters adjudication data into Electronic CRF during adjudication meetings as required.
    • Participates in project-specific meetings as required to provide CEC coordinator activity updates and event adjudication progress to completion.
    • Participates in CEC adjudication database set-up including user acceptance testing.
    • Utilizes CEC module to prepare events for adjudication by CEC members. Tracks adjudication completion by CEC members/chair within CEC module.
    • Maintains Trial Master File documentation for CEC activities.
  • Data Monitoring Committee (DMC)
    • Acts as DMC Coordinator. Co-authors DMC charter with Head of Safety. Gathers DMC member documents, , generates meeting agendas and highlights. Works with Sponsor, Clinical Operations, and/or Biostatistics to create DMC reports.
    • Hosts DMC organization meetings and data review meetings, facilitating discussion and ensuring action items are documented and completed.
    • Participates in project-specific meetings and provides DMC activity updates.
    • Maintains Trial Master File documentation for DMC activities.


  • Bachelor's degree from a four-year college or university in Life Sciences or related field; or RN diploma
  • At least 2-years’ experience in ICSR processing required, medical device or pharmaceutical
  • Clinical Events Committee adjudication coordination experience a plus
  • Knowledge of Data Monitoring Committees a plus
  • Understanding of medical terminology and industry acronyms
  • Competence with Microsoft Word and Microsoft Excel
  • Ability to perform basic searches via the internet or other comparable data repositories
  • Demonstrates attention to detail and organizational skills, develops time management skills, pro-active and displays a professional demeanor with focus on compliance and responsibilities
  • Good verbal and written communication skills
  • Excellent interpersonal skills
  • Ability to work collaboratively and effectively in a team environment
  • High attention to detail and level of accuracy
  • High degree of tact, judgment and discretion
Lower Gwynedd
Job Type
Full-Time Regular
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