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PV SUBMISSION SPECIALIST
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PV SUBMISSION SPECIALIST

Zenith LifeScience
South Plainfield, NJ

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Job Details

Full-time
$70,000 - $80,000 a year

Qualifications

Adverse event reporting
ICH guidelines
Adverse drug reaction monitoring
Patient safety and incident reporting systems

Full Job Description

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.

Responsibilities:

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

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 [email protected] for direct consideration or question.

Posted on 07/15/2022

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