Safety Data Management Specialist

Safety Data Management SpecialistJob 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 EnglishAdditional 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.