Safety Case Management Product Specialist

1-3 years

$90K/yr - $100K/yr

12 May 27, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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 the Regulatory Intelligence team and Safety Data Management to maintain accurate reporting rules in the Safety Database.

Description:

Key Responsibilities:

Daily Operations Management:
- Manage the daily operational activities of the Global Submissions Team within Case Processing.
- Ensure timely submission of Global ICSRs to various Health Authorities, License Partners, and CROs.
- Monitor the Global submissions mailbox to address high-priority emails/queries from health authorities/license partners regarding ICSR submissions.
Submission and Reporting:
- Prepare local paper submissions to the US FDA in accordance with client processes.
- Address daily worklists 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 other Health Authorities.
- Ensure timely submission of reports to global partners based on defined timelines as per the PVA.
- Submit expedited ICSR reports to Ethics Committees and Investigators as per country requirements.
Database Management:
- Monitor the safety database for failed transmissions and resolve issues promptly.
- Prepare safety ICSR submission packages for Health Authorities as per requirements.
- Follow up with the Case Processing team and Medical Reviewers for timely case corrections.
Training and Support:
- Provide training and support to newer members of the submission team.
- Review Pharmacovigilance Agreements and Safety Management Plans to identify new requirements/updates for configuring reporting rules in the safety database.
- Configure clinical studies in the database, review clinical trial protocols, and configure reporting rules as per regulations.
- Support local safety managers daily for all ICSR submission-related matters.
Compliance and Analysis:
- Identify root causes for late ICSR submissions and provide corrective and preventive actions to the Compliance and Business Management team.
- Investigate, analyze, and act on health authority queries promptly.
- Assist the Global Pharmacovigilance team with various projects to enhance system performance.

Qualifications/Experience:

Education:
- Bachelor of Science or related healthcare degree preferred.
Experience:
- 1-3 years of Submission Experience.
- Demonstrated proficiency in safety database functionality.
- Drug Safety experience includes processing AE/SAE reports, generating narratives, queries, working within safety databases, and regulatory submissions.
- Relevant experience in the pharmaceutical, biotechnology, or CRO industry in related areas such as Medical Affairs, Clinical Data Entry and Management, Clinical Monitor, Regulatory Affairs, or Quality Assurance.
Skills:
- Knowledge and understanding of global safety reporting regulations and guidelines including FDA, ICH, and EU regulations and requirements for Pharmacovigilance.
- Knowledge of the ARGUS Safety Database.
- Experience in case processing.
- Experience with expedited ICSR submissions to Health Authorities, Ethics Committees, and Investigators.
- Knowledge of medical device submissions.

Term & Start:

Contract Duration:
- 12-month contract, with the possibility of a 12+ month extension.
Interview Process:
- 2 video interviews, starting 2-3 weeks from an offer.
Work Schedule:
- Full-time, 40 hours/week.
- Hybrid schedule – on-site 2 days a week (Tuesday and Wednesday).
Benefits:
- Medical, Dental, Vision insurance, and 401k available.

Location & Compensation:

Location:
- Princeton, NJ (Hybrid – on-site 2 days a week)
Pay Range:
- Base salary: $90,000/yr - $100,000/yr

Featured Benefits:

Medical insurance
Vision insurance
Dental insurance
401(k)

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Safety Case Management Product Specialist

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