Department: PV (Clinical Operations)
The PV Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Submission specialist will perform the reconciliation of submission dates and assist with site audit requests. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.

SKILLS REQUIRE:

• Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
• Knowledge of the ARGUS Safety Database
• Knowledge and prior experience in case processing*
• Experience with managing vendors, partners, and/or CRO’s preferred

EDUCATIONAL AND/OR EXPERIENCE REQUIREMENTS:

• Bachelor’s or higher degree in Biology, Biotechnology or closely related field required
• Minimum of 2 years drug safety experience required
• Demonstrated proficiency in safety database functionality
• Global Drug Safety Case processing experience
  Job Type: Full-time
  Salary: $70,000.00 to $80,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

• Posted on 07/15/2022

• Prepare global submissions. Reviews regulatory issues with supervisor, as necessary, and assists in the negotiation of submission issues with agency personnel
• Prepare local paper submissions to FDA in accordance with company processes
• Complete all on time submissions to all applicable reporting destinations
• Generate, Review, and Transmit to all schedule reports to Global Health Authorities including but not limited to FDA European Agencies, Health Canada, etc
• Generate CIOMS I form, 3500 FDA MedWatch Form or similar to global partners based on defined timelines
• Prepare CIOMS I form is a reporting form, not primarily intended for electronic exchange between databases, linking the CIOMS I form provide by ICH-FDA.
• Monitors the safety database for failed submissions
• Maintain day-to-day operations of a large paper and electronic archive.
• Verification of regulated documents via workflows within electronic document management system.
• Responsible for maintenance of all Regulatory and FDA correspondence
• Ensure compliance with corporate and departmental standard operating procedures Contributes to development of standardized practices, procedures, metrics and measures productivity and performance within PV Operations.
• Prepares safety information for submission to local PV representatives
• Planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic format
• Process adverse event information received by the Drug Safety and Pharmacovigilance department and assist in the preparation of internal and external reports
• Follow-up with Local Safety Managers to ensure on-time submissions and request details on late submissions
• Close interaction with authoring community to track availability of deliverables
• Liaise with functional source areas to ensure documents are compliant with authoring style guide
• Collaborates with Safety Data Management, Compliance and Business Management and local PV representatives to maintain accurate reporting rules
• Verification of regulated documents via ARGUS
• Assist in the ensuring ICSR readiness for inclusion in individual and aggregate reports (PSURs, PADERs, etc.)
• Responsible for review and maintenance of reporting rules within the Argus Safety Database
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the FDA and ICH.
• Configuration of Reporting rules and distribution of auto-scheduled expedited reports
• Performs oversight of the Submissions Mailbox
• Expedited report acknowledgements are monitored for successful transmission
• E2B failures are monitored and investigated immediately
• Provide training and support to newer members of the submission team