Submissions Specialist Global PV Operations, PharmaceuticalsSummary:
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.
- 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.
- 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.
Education and Experience:
- Proven ability to work in a team environment
- Proven ability to manage multiple projects simultaneously
- 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