Safety Data Management Specialist
At a glance
Mid-level Data Architecture & Governance role at Integrated Resources INC. Peapack · contract.
Pay not stated Data Architecture & Governance salary
dataroles summary, based on the employer's posting.
What you'll do
- Assess adverse drug reports to establish product safety and decide whether local or aggregate regulatory submissions are needed
- Process safety cases by checking validity, seriousness, special scenarios, deadlines, accuracy and consistency, then record your findings
- Choose the right case workflow, flag complex cases, and write or revise case narratives
- Arrange case follow-up, including requests for more information, and check completed records against process rules
- Coordinate safety-data collection and reconciliation with local partners and other stakeholders
What you bring
- Fluent spoken and written English
- Computer literacy and the ability to make routine decisions and raise issues while working under supervision
Who this fits
This role suits someone comfortable processing safety cases within set procedures and working under supervision in a matrix organization. The position is an onsite contract role in Peapack and reports to a country or team safety lead, or a safety officer.
From the employer
Job Responsibilities:
- 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
All your information will be kept confidential according to EEO guidelines.
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