Senior Safety Associate

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.

Responsibilities

  • 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 (periodic safety reports, Argus line listings)
    • Represents Safety Services in quality assurance activities including audits. Independently develops study and departmental 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; MedDRA coding guidelines
    • Serves as mentor and coach to less experienced Safety Services team members and non-Safety Services staff
    • Performs any additional related work as required and assigned by Head of Safety Services
  • Individual Safety Case Reports (ICSRs)
    • Acts as Lead Safety Team member for clinical studies budgeted for safety case processing
    • Develops adverse event case report form in conjunction with Data Management
    • 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, pre- and post-market for medical devices and investigational drugs
    • 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 Argus safety database. Performs MedDRA coding of event terms and medical history utilizing MedDRA guidance documentation. 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 CEC Coordinator. Co-authors CEC charter with Head of Safety. Gathers CEC member documents, tracks events for adjudication, prepares adjudication document packages, generates meeting agendas and highlights. Participates in project-specific meetings as required. Participates in CEC adjudication database set-up.
    • Serves as a CEC subject matter expert for Company and Sponsor
  • Data Monitoring Committee (DMC)
    • Acts as DMC Coordinator. Co-authors DMC charter with Head of Safety. Gathers DMC member documents, prepares DMC meeting documents (reports, agenda, listings), generates meeting agendas and highlights. Participates in project-specific meetings as required.
    • Serves as a DMC subject matter expert for Company and Sponsor

Qualifications

  • Bachelor’s degreefrom a four-year college or university in Life Sciences or related field; or RN diploma
  • At least 5-years’ experience required of ICSR processing, or combination of 5 years ICSR processing and clinical trial research coordination
  • Basic knowledge of regulatory environment governing safety and risk management activities required
  • Solid understanding of ICH-GCP required
  • Knowledge of pre- and post-marketing medical device vigilance and Pharmacovigilance preferred
  • Clinical Events Committee adjudication coordination preferred
  • Knowledge of Data Monitoring Committees preferred
  • 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

City
Lower Gwynedd
State
PA
Job Type
Full-Time Regular
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