Senior Analyst Engineer II
Job Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
POSITION SUMMARY:
Support Pharmacovigilance and Safety Services systems including Argus and other supporting systems in line with ICON Business Strategy and IT Governance and Control objectives.
LOCATION: Chennai ( Office or Home)
EDUCATION REQUIREMENTS:
Bachelor’s Degree in Computer Science or related field with at least 3 years of IT or direct Drug Safety Systems support, or equivalent combination of education, training and experience
JOB FUNCTIONS/RESPONSIBILITIES:
• Provide Drug Safety application support including but not limited to; user account maintenance, product setup, study setup, and license setup, and codelist maintenance.
• Generate Validated standard line listings from Argus safety database for DSURs, 6-monthly line listings, business partner exchange, PSURs/PBRERs.
• Generate Ad hoc safety data listings (non-validated) for internal customers
• Troubleshooting technical issues that may arise during E2B import, E2B exchange and/or global transmission of ICSRs and aggregate safety data to regulatory authorities, business partners and applicable vendors
• Provides technical/functional assistance in the Drug Safety application support function and in planning and deployment of new releases
• Collaborates closely with IT and PVSS department in setting a high standard with respect to protection of safety data systems and access.
EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS:
• Ability to establish and maintain effective working relationships with coworkers, managers, interdepartmental stakeholders and applicable vendors (CROs)
• Able to adjust to multiple demands and shifting priorities and react constructively in a high-energy, fast paced environment
• Direct experience with Argus, other safety data repositories and electronic data capture (EDC) platforms
• Experience with reporting platforms, data visualization tools, and SQL/PLSQL
• Excellent interpersonal and communication skills, both written and oral
• Understands safety database structures and is familiar with data retrieval tools, and coding dictionaries such as MedDRA, WHODrug
• Experience with supporting time-sensitive requests for safety data listings during internal audits as well as regulatory authority inspections
• Excellent project management skills with the ability to align internal and external resources
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, ****** orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
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