Safety Data Management Specialist

Integrated Resources Inc.; Peapack-Gladstone (NJ); On-site; USD 70,000 - 100,000; Full time

Job summary

A health and safety services company in New Jersey is seeking a professional to manage pharmacovigilance case processing and ensure compliance with regulatory requirements. Responsibilities include reviewing reports of adverse drug experiences and developing expertise in safety data collection. Ideal candidates will have healthcare-related education and fluency in English. This role emphasizes accuracy and collaboration with key stakeholders.

Qualifications

• Health care Professional or equivalent experience preferred.
• Ability to solve routine problems and to surface issues constructively.
• Fluency in spoken and written English is required.
• Experience in use and management of relational databases preferred.

Responsibilities

• Review reports of adverse drug experiences for safety profile.
• Determine local submission of safety reports.
• Carry out case processing activities.
• Review case data for accuracy, seriousness, validity, timelines, and special scenarios.
• Process cases and assess workflow to match required processing steps.
• Escalate complex cases and follow up as needed.
• Write and edit case narratives and follow-up requests as required.
• Review processed cases to verify accuracy and data reconciliation with partners.
• Liaise with partners and stakeholders regarding safety data collection and reconciliation.
• Develop expertise in applicable regulations, SOPs, and data entry conventions in safety databases.
• Determine reportability of scheduled reports and ensure regulatory adherence.
• Contribute to local, internal, and external safety activities as appropriate.

Skills

Fluency in spoken and written English

Ability to solve routine problems

Ability to make basic decisions

Computer literacy

Experience in medical writing

English fluency

Education

Health care Professional or equivalent experience

Tools

Relational databases

Job description

• Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Client’s products and to meet regulatory requirements.
• Determination of local submission of individual and, where appropriate, aggregate safety reports
• Carry out case processing activities
• Review, rank, verify, process and document case-related information: ENT terms; validity, seriousness, special scenarios; timelines; accuracy and consistency.
• Process cases based on these assessments
• Review case criteria to determine appropriate workflow for case processing
• Assess case to distinguish those with particular complexities and/or specific issues, and escalate appropriately
• Write and edit case narrative
• Determine and perform appropriate case follow-up, including generation of follow-up requests
• Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
• Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation
• Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
• Determine report ability of scheduled reports, ensuring adherence to regulatory requirements
• Consistently apply regulatory requirements and Client’s policies
• Participate, as appropriate, in local, internal and external safety activities

Reports to Country Safety Lead or Safety Team Lead or Safety Officer (depending on local organization and safety group size)

What is the minimum education experience required?:

• Health care Professional or equivalent experience preferred
• Ability, with supervision, to solve routine problems and to surface issues constructively
• Ability to make basic decisions with an understanding of the consequences
• Ability to achieve personal objectives while meeting departmental standard of performance
• Ability to work under supervision in a matrix organization
• Fluency in spoken and written English

Additional Skills:

• Experience in Pharmacovigilance and/ or data management preferred but not required
• Experience and skill with medical writing an advantage
• Demonstrated computer literacy
• Experience in use and management of relational databases preferred

Additional Information

All your information will be kept confidential according to EEO guidelines.