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Submissions Specialist Global PV Operations, Pharmaceuticals

GForce Life Sciences
Dayton, New Jersey, US
Closing date
Jan 15, 2022

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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Submissions Specialist Global PV Operations, Pharmaceuticals


GForce is seeking an experienced GPV Submission Specialist for a new contract opportunity with a growing pharmaceutical company to assist with PV ICSR Submissions.

Role Responsibilities:
  • Play an integral role in the management of daily operational activities of the Global Submissions Team within Case processing.
  • Responsible for managing the timely submission of Global ICSRs to various Health Authorities, License Partners, and CROs.
  • Monitoring of Global submissions mailbox to address all the high-priority emails/ queries received from health authorities/ license partners related to ICSR submissions.
  • Prepare local paper submissions to US FDA in accordance with Otsuka processes
  • Responsible to address daily worklist to complete submissions to all applicable reporting destinations
  • Generate, Review, and Transmit reports to all Global Health Authorities including but not limited to FDA European Agencies, Health Canada, and various other Health Authorities.
  • Timely submission of appropriate reports to global partners based on defined timelines as per the PVA.
  • Responsible for timely submission of expedited ICSR reports to Ethics Committees and Investigators based on the country requirements.
  • Monitoring the safety database for failed transmissions to resolve the issue in a timely manner.
  • Involved in preparing safety ICSR submission package to Health Authorities as per the requirements.
  • Follow-up with Case Processing team and Medical Reviewers to request appropriate case correction for timely submissions of reports.
  • Provide training and support to newer members of the submission team
  • Collaborate with Regulatory Intelligence team, Safety Data Management to maintain accurate reporting rules in the Safety Database.
  • Review of Pharmacovigilance Agreements and Safety Management Plans to identify new requirements and/or updates for configuration of reporting rules in the safety database.
  • Responsible for configuring clinical studies in the database, reviewing clinical trial protocols, and 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 the 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.

Related Experience:
  • 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
  • Knowledge and experience with working on expedited ICSR submissions to Health Authorities.
  • Knowledge of Medical device submissions
  • Knowledge of expedited ICSR submissions to Ethics Committees and Investigators.

Desired Skills:
  • Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
  • Strong communication and writing skills
  • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
  • Knows how/when to apply an organizational policy or regulatory procedures to a variety of situations. Ability to work under pressure to meet tight timelines
  • Able to work effectively in a matrix environment Strong attention to detail along with the ability to problems solving.

  • Proven ability to work in a team environment
  • Proven ability to manage multiple projects simultaneously

Education and Experience:
  • Degree preferred to be in Bachelor of Science or related healthcare degree however may be waived for relevant experience**
  • Minimum of 2 years Drug Safety experience required*
  • Demonstrated proficiency in safety database functionality
  • Prior ICRS submission experience is required.

  • 12+ month contract with potential to extend
  • Remote but future travel to NJ is possible
  • Healthcare benefits available
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