Pharmacovigilance Database Developer SME

The Pharmacovigilance Database Developer SME performs independently or as a key multi-functional team member in identifying, planning, developing and deploying FDA’s Adverse event applications and other technology solutions that can involve multiple physical locations and business units. Acts as the single point of contact for database administration and escalations for a Federal project.

Chickasaw Nation Industries, Inc. serves as a holding company with multiple subsidiaries engaged in several lines of business (Technology, Infrastructure & Engineering, Health, Manufacturing, Public Safety, Consulting, and Transportation) for the federal government and commercial enterprises. A portion of our profits is used to support Chickasaw citizens. We are proud to support the economic development and long-term viability of the Chickasaw Nation and its people. CNI offers premium benefits eligible on the first day of hire to full time employees; (Medical - Dental – Vision), Company Life Insurance, Short-Term and Long-Term Disability Insurance, 401(K) Immediate Vesting, Professional Development Assistance, Legal Aid Assistance Program, Family Planning / Fertility Assistance, Personal Time Off, and Observance of Federal Holidays.

As a federal contractor, CNI is a drug-free workplace and adheres to the Federal Controlled Substance Act.   

ESSENTIAL REQUIREMENTS

• The ability to obtain, maintain and access classified information at the Public Trust level. 

• Oracle DBA certification.

• Driver’s License.

• Strong technical and functional experience in Oracle database Administration 10g, 11g, 12c, and 19c. PL/SQL, SQL*Plus, SQL*Loader, TOAD and UNIX shell scripting. Experience with visual dashboarding tools such as QlikSense and Tableau is preferred.

• Experience with complex XML files and data is required. Experience with documenting artifacts related to software development, performing unit testing and integration testing is required. Experience in code debugging, SQL tuning and performance optimization of PL/SQL programs.

• Federal project implementation experience at HHS or FDA is mandatory. AWS Data migration service experience is essential. Experience with HHS/FDA government cloud implementation is preferred.

• Experience with Regulatory dictionaries such as MedDRA and WhoDrug is preferred.

• Experience with Scalr tools for AWS console monitoring, debugging and troubleshooting.

• Expertise on AWS EC2 is essential for day-to-day operations.

• SSO configurations and implementations.

• Able to perform data migrations between 10g to 11g, 11g to 12c, 12c to 19 c.

• Able to optimize databases, indexing and partitioning schemes.

• Understanding of HHS or FDA security, compliance and processes is essential to implementation of day-to-day tasks.

• Ability to obtain public trust clearance is essential for timely and expedient onboarding.

• Expert in various activities such as Performance Tuning, Backup and Recovery.

• Knowledge of FDA-mandated policies and regulations relevant to contract management, assessments and analyses.

• Demonstrated experience managing stakeholder relationships at senior levels of government.

• Demonstrated program management skills including previous experience in contract and grants management.

• Ability to plan and oversee projects with project management software tools and methodologies.

• Skilled in facilitating teamwork and coordinating efforts for the successful achievement of goals.

• Excellent supervisory and management skills with ability to resolve conflicts, grievances, confrontations or disagreements in a constructive manner.

• Exceptional organization skills with ability to manage effectively multiple projects and priorities.

• Excellent verbal and written communication skills with solid presentation skills and ability to write federal contract proposals.

• Exceptional customer service and relationship-building skills.

• Ability to schedule, plan and lead meetings.

KEY DUTIES AND RESPONSIBILITIES

Essential Duties and responsibilities include the following. Other duties may be assigned. 

• Has experience in implementing Pharmacovigilance IT projects with hands on experience for database migrations, mappings, data-cleanup and identification.

• Must be aware of Federal regulations for case compliance, safety surveillance and must be familiar with CFR mandates released for post-market adverse event reporting in the last 6-7 years.

• Preferably have experience on FDA’s