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 CDER (Drug) and CBER (biologic) product reporting guidance.

Must be aware of pharmacovigilance changes coming up for the industry for pre-market initiatives in the HL7 R3 space.

Must be aware of Product quality submission guidelines along with expertise on existing FAR, BPDR form regulations.

Must be familiar with MedDRA upgrade life cycles and process through automation.

General awareness of industry standards in support of Pharmacovigilance processes is ideal.

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 CDER (Drug) and CBER (biologic) product reporting guidance.

Must be aware of pharmacovigilance changes coming up for the industry for pre-market initiatives in the HL7 R3 space.

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

Able to optimize databases, indexing and partitioning schemes.

Must be aware of standard industry tools for Pharmacovigilance such as Oracle Argus, ArisGlobals ArisG or LSMV, and AgTracker.

Should be able to support ETL and analytics development between the transactional PV tools and the analytics PV platforms including but not limited to RxLogix PVSignal, PVReports etc.

Works with geographically distant and remote teams for COTS product troubleshooting and implementations.

Successfully meets new technical challenges and finds new solutions to meet the needs of the customer. Reviews and defines the client specifications, documenting the requirements as per the prescribed standard.

Supports development of application interfaces without disrupting existing business rules and case intake processes and workflows.

Works in 24x7 production environment and provides on-call and day-to-day support.

Creates and executes a strategy to build mindshare and broad use of AWS within a wide range of customers and partners.

Expertise in Performance tuning the production database towards optimal performance based on the changes in the database storage structures due to application change requirements. Monitors and optimizes the performance of the database through database tuning – tuning applications, tuning memory, tuning disk usage, and tuning OS.

Successfully completed partitioning Oracle master tables on Exadata Database Machine.

Assists application developers convert/transition data and applications to future versions of Oracle, prepares application installation packages for Oracle applications, and implementation of architectural and/or design changes.

Monitors and Tunes Oracle RAC (Real Application Clusters) using TOAD Spotlight.

Creates backup plan design and implementation using cold/hot backups, flash copy, volume copy and RMAN backup technology.

EDUCATION AND EXPERIENCE

Bachelor’s or Master’s degree in Computer Science or a related field of study and a minimum of fifteen (15) years of relevant IT experience, or equivalent combination of education/experience.

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.

PHYSICAL DEMANDS

Work is primarily performed in an office environment. Regularly required to sit. Regularly required use hands to finger, handle, or feel, reach with hands and arms to handle objects and operate tools, computer and/or controls. Required to speak and hear. Occasionally required to stand, walk and stoop, kneel, crouch, or crawl. Must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception and ability to adjust focus. Exposed to general office noise with computers printers and light traffic.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

EOE including Disability/Vet

*Please note, that this position is contingent upon the award or funding. The essential duties, experience, education requirements, and salary are subject to change.*

The estimated pay range for this role is $125K to $150K, with the final offer contingent on location, skillset, and experience.

CNI offers a comprehensive benefits package that includes:

Medical

Dental

Vision

401(k)

Family Planning/Fertility Assistance

STD/LTD/Basic Life/AD&D

Legal-Aid Program

Employee Assistance Program (EAP)

Paid Time Off (PTO) – (11) Federal Holidays

Training and Development Opportunities

Your application submission will be considered for all potential employment opportunities with Chickasaw Nation Industries (CNI).

R8032