- Manage and document submission of vendor partners/CROs and health authorities, including monitoring and responding submissions inquiries from partners/CROs and health authorities.
- Preparation of paper submissions to FDA, review and manage daily work tasks to ensure proper reporting destinations.
- Ensure timely submission of all documents and reporting are completed and submitted by generating, reviewing, and transmitting reports to all global health authorities US, EU, Canada and others as required.
- Responsible for timely submission of specified ICSR reports to global partners, investigators and others by specific country requirements to meet deadlines
- Cross functional work with safety teams/MDs related to case processing/corrections as needed Data management and safety database
- Review of Pharmacovigilance Agreements and Safety Management Plans to identify new requirements and/or updates for configuration of reporting rules in safety database.
- Responsible for configuring clinical studies in the database, review clinical trial protocols and configure reporting rules as per regulations.
- As Submissions SME, support local safety managers on daily basis for all ICSR submission related matters.
- Identifying root cause for late ICSR submissions and to provide appropriate corrective and preventive actions to Compliance and Business Management team.
- Responsible for timely investigation, analysis, and action on health authority queries
- Monitor and address weekly ICSR submission reconciliations with local safety managers.
- Assist the Global Pharmacovigilance team with various projects to enhance system performance.
- Bachelor of Science or related healthcare degree.
- 1-3 years of Submission Experience & Medical device submissions.
- Drug Safety experience - processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
- Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry.
- System experience: ARGUS Safety Database and proficiency in MS Office Suite.
- Knowledge and prior experience in case processing.
- Knowledge and experience with working on expedited ICSR submissions to Health Authorities.
- Knowledge of expedited ICSR submissions to Ethics Committees and Investigators.
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Global PV Submissions Specialist - Princeton, United States - Clinical Resource Network (CRN)
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Description
Our client is looking to fill the role of Global PV Submissions Specialist. This role will be hybrid and based out of the Princeton office.
Responsibilities:
Required Qualifications:
If you meet the required qualifications and are interested in this role, please apply today.
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
