Company: Mosaic Regulatory Solutions
Closing Date: 13 Nov 16
Salary (£): On Application
To apply for this Drug Safety Manager role please call Julie Cooper on 07951 082482 or send your CV to: firstname.lastname@example.org
Role: Global Drug Safety Data Manager
The Global Drug Safety Data Manager is responsible for providing application and operational support for the development, maintenance, and improvement of the systems and processes of the Global Patient Safety (GPS) department. The individual in this role will work closely with GPS colleagues and other departments, including IT, to ensure the integrity and consistency of safety data while ensuring that safety data deliverables are well defined, timely, meaningful and compliant.
Other responsibilities include, but are not limited to:
Develop system/application requirements according to business needs. Collaborate with the IT department and the safety data base vendor on system updates and validation. Lead and/or contribute to the design, development, and testing of Argus configuration and functionalities.
Contribute to the development and improvement of data collection, retrieval, and submission processes. Plan and prioritize system/application improvements according to user requests and business requirements.
Lead and support safety data validation efforts, maintain documentation, and perform quality checks on data output.
Establish best practices for data retrieval and query generation. Create, run, and distribute routine and ad-hoc queries.
Desired Skills and Experience
Bachelor’s degree in computer science, technology or engineering preferred. Master’s Degree and/or advanced training in relevant fields is strongly preferred.
7 -10 years of experience in global drug development including drug safety, risk management, clinical research, biostatistics, epidemiology or other relevant field is required.
Expert knowledge of drug safety databases and related computer systems. Strong Argus experience will provide candidates with a strong advantage.
Expert knowledge of MS Office suite specifically Excel required. Database design or programming experience is a plus.
Working knowledge of global regulatory requirements and guidance documents for drug safety reporting including experience with E2B submissions.
Understanding of Pharmacovigilance internal and external environment including methodological and technical aspects.
Ability to analyze and communicate complex issues and their strategic implications for systems and processes.
Fluency in spoken and written English.
Strong interpersonal, written and oral communication skills.
Strong problem solving skills.
Demonstrated ability to work effectively with a sense of urgency in a dynamic, cross-functional matrix environment.
Key role /key roles - Drug Safety, PV , Drug Safety Manager , Argus, Global , international , Ireland , Dublin
Mosaic Regulatory Solutions Ltd
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