PRINCIPAL RESPONSIBILITIES: List major responsibilities and duties of the position. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. Describe those quantitative aspects of the position which reflect measures that are applicable to the position’s major responsibilities or end results. Responsibilities include: • Manage E2B submissions per standardized operating procedural document; review ICSRs for local reportability, make submit / no submit determination, monitor successful transmission • Perform other functional duties associated with Local Case Reporting (LCR)/E2B; produce CIOMS / Medwatch and fax/email, distribute, and upload to document storage • Perform Outbound Submission Tracking (OST) activities as needed • Monitor transmissions / E2B case failure monitoring and (if appropriate) handling • Liaise with Support Desk and / or Case Processing personnel • Prepare issues for escalation up to manager which may be escalated to QPPV (i.e. clearly articulate the problem) • Document and track compliance related data • Perform reconciliation • Participate in User Acceptance Testing (UAT) for upgrade / enhancements to LCR including support of script writing • Perform archiving activities as necessary • Participate in process improvement Global Medical Safety Job Description Submission Specialist, Global Safety Reporting FRM-09712, Version 8.0 2 of 3 Training and Development: • Maintain knowledge of department policies and procedures • Complete development activities as applicable • Maintain knowledge on worldwide regulations / guidance related to single case processing activities DECISION-MAKING AND PROBLEM-SOLVING: Describe the types of decisions which are made, reviewed or referred. Describe the types of problems solved or referred. Indicate the degree to which decisions made and problems solved are circumscribed by procedure, policies, standards, or regulations. (TYPE BELOW THIS LINE) See Responsibilities REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides. Reports directly to GSR Manager, PV Operations, GMS RESPONSIBILITY FOR OTHERS (If applicable): Describe the nature of supervision exercised over others by this position. Please ensure that it shows the incumbent’s name and position titles of peers, staff and supervisor. Include regular/casual full-time and part-time employees, temporaries, co-ops, consultants, etc. EMPLOYEES SUPERVISED: EXEMPT: NONEXEMPT: PART-TIME: TEMPORARY: CO-OP: CONSULTANT: WORKING RELATIONSHIPS/INTERFACES: Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature. Global Medical Safety is a functional area within the Global Medical Organization Primary Interface is with Senior Submission Specialist, Submission Scientist and Manager. Additional interface will include but not limited to interactions with GMS Support Desk and Case Processing. Global Medical Safety Job Description Submission Specialist, Global Safety Reporting FRM-09712, Version 8.0 3 of 3 EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable. Degree and/or relevant work experience Working knowledge of safety database systems, local case reporting, queries Working knowledge of related applications (e.g. WebTrader, OST, LCR, ArisG, Argus) Basic understanding of regulatory reporting obligations Attention to detail Sense of urgency Ability to recognize when and what to escalate Familiarity with organization and products Organizational skills Problem solving abilities RELATED EXPERIENCE: 0-2 years 9 to 12 years 3 to 5 years 13 to 15 years 6 to 8 years 15+ years