Associate Safety Systems Manager - IQVIA Biotech

IQVIA Biotech is seeking an Associate Safety Systems Manager:

BASIC FUNCTIONS:

Responsible for facilitating and leading all technical aspects of Safety data exchanges between clients or vendors and IQVIA Biotech according to ICH-GCP guidelines, regulatory requirements, IQVIA Biotech SOPs and study specific procedures.  Interacts with clients and serves as the primary point of contact for database administrators and IT departments on technical Safety matters. Demonstrates an ability to analyze and translate business or change requirements into system configuration solutions for clients.  Leads technical projects of substantial scale and/or complexity aimed at improving Safety Management departmental procedures.

Responsibilities include providing oversight, ongoing identification and implementation of safety process refinements, acting as liaison between the technical, clinical, training, and safety departments. Generates or updates departmental literature and/or controlled quality documentation, including but not limited to SOPs and WPs referencing Safety applications. Provides administrative and Safety application support functions in the form of troubleshooting, system maintenance and/or technical guidance for the end-user community.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Attends client and/or vendor calls as a subject matter expert for technical Safety projects
• Evaluates and leads most appropriate data import process based on company policies and project specific requirements
• Responsible for planning and performing database extracts for the purposes of compliance, training, metrics, and/or interim data transfers
• Analyses, evaluates and implements new or revised procedures affecting Safety Management applications
• Collaborates with Safety leadership for assessment and implementation planning of the impact on technology across Safety Management platforms
• Leads the validation of Safety System updates and upgrades; including but not limited to the development of test scripts and traceability of business requirements
• Performs Safety database administration support
• Assists with the upgrade and versioning procedure of Safety System coding dictionaries
• Implements and maintains tools and technologies used in product life cycle Safety to include reporting, compliance, training, and other Safety business requirements
• Ability to create reports from raw code and ad-hoc system reports to address inquiries from clients, vendors, and/or IQVIA Biotech staff 
• Responsible for monitoring and training with start-up configuration and ongoing activities of Safety Management owned systems
• Evaluates processes and systems to identify and implement efficiencies across Safety Management
• Composes, updates, and provides input for departmental procedural documentation including SOPs and Working Practices
• Ability to troubleshoot and resolve technical issues that may arise in Safety applications
• Tracks and responds to concerns raised relevant to the Safety System(s) with professionalism

• Ability to evaluate and escalate issues to the relevant group in a timely fashion
• Performs other related duties as assigned or requested by manager

KNOWLEDGE, SKILLS AND ABILITIES:

• In depth knowledge of safety relational database systems, including workflow configuration, etc.

• In depth knowledge of clinical research processes and medical terminology.
• Ability to write and debug PL/SQL, Oracle SQL, and MySQL
• Broad understanding of clinical trial safety and product development.
• Excellent written and verbal communication skills. Able to effectively express complex ideas.
• Positive attitude and ability to interact effectively with all levels of staff to successfully coordinate and execute Safety Management departmental activities.
• Knowledge of issues/considerations involved with collecting safety data in an electronic data capture environment.
• Knowledge of current ICH/GCP guidelines applicable to the conduct of clinical research.
• Excellent organizational and interpersonal skills.
• Excellent attention to detail.
• Demonstrates excellence in customer service and professionalism.
• Demonstrates honesty and integrity during interactions with others. Works effectively with project team members. Accepts constructive feedback without becoming defensive.
• Independently prioritizes time effectively based on departmental needs. Consistently meets deadlines.
• Assists with compliance tracking as needed for relevant company policies and procedures.
• Advanced software skills in MS Excel, MS PowerPoint, MS Word, etc.

• Ability to work independently, prioritize effectively and work in a matrix team environment. 
• Prior experience working with safety database systems.
• Ability to rent automobile

PHYSICAL REQUIREMENTS:

• Ability to sit for long periods of time with some walking, standing, bending, stooping, or carrying of light objects.
• Ability to use hands and fingers to handle and manipulate objects and/or operate equipment.
• Ability to occasionally travel domestically and internationally if required.

MINIMUM RECRUITMENT STANDARDS:

• Bachelor’s Degree or equivalent in life sciences or clinical research preferred
• 5 years of work experience in Oracle Argus Safety support for clinical trials and pharmacovigilance processing

• Experience in writing, executing, and supporting software validation projects preferred

• Knowledge of electronic data capture preferred.

CLASSIFICATION:

This position is classified as exempt from the Fair Labor Standards Act; employees are not eligible for overtime compensation.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.