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Job Description

The “IT Systems Manager” will work along with IT systems Manager UK in accomplishing IT activities by ensuring compliance with company’s SOPs, regulatory submission timelines and customer / client requirements and on time delivery of the IT projects.


      Knowledge, skills and experience required:


·                Minimum: a graduate degree in Computer science with previous experience of working with Safety and medical information database is desirable.

·                Minimum 5 years of relevant Safety Database work experience.

·                Knowledge of CFR Part 11, Annex 11 Computer System validations, UK and European Safety systems and IT systems validation requirements.

·                Good understanding of the principles of Pharmacovigilance, including statutory requirements for Pharmacovigilance data and working knowledge of Standard Operating Procedures relating to the transfer of Pharmacovigilance data.

·                Meticulous approach to the maintenance of data files and protecting the client and company data at all times.

·                Proficiency in using MS Office, Oracle SQL and testing the software application is a must.

·                Ability to organize, prioritize and plan projects, work effectively and provide timely updates on the ongoing tasks to the IT Systems Manager.

·                Good time management skills.

·                Good communication skills.

·                Good presentation and written communication skills.

·                Strong team player to contribute effectively to the smooth running of the Company’s Pharmacovigilance department.