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Safety and Data Management Specialist

职称: Safety and Data Management Specialist
合同类型: Contract
位置: Tadworth
行业:
开始日期: ASAP
参考: MB-SDMSpecialist
联系人姓名: Megan Bristow
联系电子邮件: megan.bristow@tanint.com
招聘发布: September 04, 2020 17:43

职位描述

Megan is working with a well-established organisation who are looking for an experienced Safety and Data Management Specialist on a part-time basis (15 hours per week) on a 6-month contract. The role will be responsible for reviewing, preparing and completing reports of adverse experiences, to determine the safety profile of the company's products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports.

It is based remotely/in Tadworth and has competitive rates.


Responsibilities:

• Carry out case processing activities

• Review, rank, verify, process and document case-related information: event 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 cases 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 reportability of scheduled reports , ensuring adherence to regulatory requirements

• Participate, as appropriate, in local, internal and external safety activities


Requirements:

• Experience in pharmacovigilance and/or data management 

• Experience and skill with medical writing an advantage

• Health Care Professional or equivalent experience preferred

• Ability, with supervision, to solve routine problems and to surface issues constructively

• Strong communication skills

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