• The Safety Systems Analyst interfaces with both the Pharmacovigilance group within Medical Affairs Department and Global IT and responsible for identifying and defining adequate systems and databases to support consistent and accurate Pharmacovigilance data collection, data analysis, report generation, and submission tracking.
• This role facilitates user requirements gathering, implements user requirements and acts as a technical expert for designing customized/complex database solutions, queries and reports for internal and external customers, including regulatory authorities like FDA and EMA.
• This position requires a strong knowledge of Pharmacovigilance terminology and Database (e.g. Oracle AERS, ARISg, ARGUS) and excellent technical, analytical and problem solving skills pertaining to safety database systems.
• Individual should have excellent communication skills and interpersonal skills and should have the ability to learn quickly and train others within the team.
• Broad knowledge of relevant ICH guidelines, as well as FDA and EU Regulations is a Plus.
Bachelor's degree in scientific discipline, life- or computer science or equivalent
At least 3-5 years of previous experience in Data Management or related area
To know more about this position, please contact:
Jeff Demaala
973-606-3249
Job details are sourced from the employer's original posting.
Open job postingAbout the company
We provide cost-effective, high quality IT resources to meet talent needs through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera has been a leader in IT staffing for over 24 years and is one of the largest diversity IT staffing firms in the industry. We are known for our high-touch, customer-centric approach, offering our clients unmatched quality, responsiveness and flexibility. We are appreciated by our clients for our streamlined execution, highly efficient service and exceptional talent management that go above and beyond traditional staffing services. Collabera has been named the Best Staffing Firm to Work For in the large firm category by Staffing Industry Analysts, the global advisor on contingent work, for four consecutive years.