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.