Submission specialist

Consultant, GPV Case Management Product Specialist, Pharmaceuticals

Summary

Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Team within Case processing.

This candidate will collaborate with Regulatory Intelligence team, Safety Data Management to maintain accurate reporting rules in the Safety Database.

Description

• Play an integral role in management of daily operational activities of the Global Submissions Team within Case processing.
• Responsible for managing 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 the clients 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’s 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
• 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.
• Assist the Global Pharmacovigilance team with various projects to enhance system performance.

Qualifications / Experience

• Degree preferred to be in Bachelor of Science or related healthcare degree
• 1-3 years of Submission Experience
• Demonstrated proficiency in safety database functionality
• Drug Safety experience is defined as actual 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, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Monitor, Regulatory Affairs, or Quality Assurance

Required Skills Include :

• 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 expedited ICSR submissions to Ethics Committees and Investigators

Term & Start

• 12-month contract, open to 12 month extension
• 2 Video Interviews - Start 2-3 weeks from an offer
• Full time, 40 hours / week
• Hybrid Onsite 2 days a week onsite (Tuesday and Wednesday)
• Benefits available (Medical, Dental, Vision, 401k)

Last updated : 2024-05-17