Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.
Job Description• 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.
QualificationsBachelor'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
Additional InformationTo know more about this position, please contact:
Jeff Demaala
973-606-3249
Skills Required
- Bachelor's degree in scientific discipline, life- or computer science or equivalent
- 3-5 years of previous experience in Data Management or related area
