Global PV Submissions Specialist
📋 Role Overview & Responsibilities
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
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.
Required Qualifications
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
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 https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
Frequently Asked Questions
How do I apply for the Global PV Submissions Specialist position at Solomon Page? ▼
Click the “Apply for this Position” button on this page to submit your application directly to Solomon Page without recruitment intermediary fees.
Is this position eligible for remote work or visa sponsorship? ▼
This position is located in Princeton, NJ with potential relocation and sponsorship assistance depending on candidate qualifications.
Are there any candidate fees on Hirely? ▼
No. Hirely is completely free for candidates. We never charge registration fees or placement fees.
Legitimate employers will never ask you to transfer funds, purchase equipment from unauthorized vendors, or pay application/visa fees. Hirely rigorously monitors listings, but always verify communication is from official corporate email domains.
Learn how to protect yourself against employment fraud →