Global PV Submissions Specialist

2 weeks ago

Princeton, United States Clinical Resource Network (CRN) Full time

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 and connect with us on Facebook and LinkedIn.


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