GPS Systems Manager

SUMMARY/JOB PURPOSE (Basic purpose of the job):

Drug Safety Systems Associate III will report to the Director of Global Patient Safety Systems and be responsible for serving as a system functional expert on the Safety applications and responsible for creating and generating various reports, including aggregate reports for GPS operations and risk-benefit teams. This position is mainly responsible for supporting the analytical requirements of the GPS organization.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Responsible for the development, validation, and generation of reports for data analysis, periodic reports, ICH PSUR/DSUR line listings, and ad-hoc queries.

• Create custom and ad hoc queries to extract data from the system and apply a quality control procedure to ensure correctness and completeness to the listings.

• Create or improve processes for data extraction, management, and quality control.

• Assist in implementing and managing the effective structure, procedures, and tools to ensure aggregate reports and other deliverables are completed with high quality.

• Assist with developing and maintaining GPS systems SOP, Procedures, Forms, Work Instructions, and guidance documents, and conduct periodic reviews and update as necessary.

• Closely work with GPS business team members to gather requirements and oversee the implementation of the technical solutions to the requirements.

• Work with GPS business to help define and document business processes and system requirements.

• Participate in GPS systems validation and UAT activities adhering to 21 CFGR Part 11 guidelines.

• Assist in evaluating the technical and analytical needs of the GPS department and maximize the capabilities of the safety and other GPS-related systems.

• Liaison between Global Patient Safety, QA, IT & Digital Transformation teams.

• Assist in the preparation and support of audits and inspections.

• Understand regulatory changes as they impact the organization.

• Coordinate with new initiatives and participate in implementing new tools and technology solutions.

• Work with GPS business to help define and document business processes and system requirements.

• Participate in GPS systems validation and UAT activities adhering to 21 CFR Part 11 guidelines.

• Participate in analyzing and performing impact assessment on the change requests, initiate change controls and oversee implementation.

• Oversee development and maintenance of safety systems configurations.

• Oversee vendor activities and their deliverables.

• Perform additional tasks as needed or assigned to meet the needs of the team, and to support GPS business needs.

• Participate in analyzing and performing impact assessment on the change requests, initiate change controls and oversee implementation.

• Oversee MedDRA & WHO drug dictionaries, Axway E2B Gateway transactions and resolve any issues working with IT/Digital and business team members.

SUPERVISORY RESPONSIBILITIES:

No supervisory responsibilities.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/BA degree in a related discipline and seven years of related experience; or,

• MS/MA degree in a related discipline and five years of related experience; or,

• PhD in a related discipline and zero years of related experience; or,

• Equivalent combination of education and experience.

Experience:

• Significant experience in pharmacovigilance with a proven record of supporting safety tools/solutions, preferably Argus, Axway and other PV-related systems.

• Significant experience with analytical and business intelligence tools, preferably PV Reports or equivalent.

• Experience with RDBMS and SQL/PL-SQL programming.

• Experience in GxP Computer system process.

• Experience with SDLC, OnPrem, and SaaS deployment models.

Knowledge, Skills and Abilities:

• Knowledge of biotechnology/pharmaceutical sector.

• Knowledge of regulatory framework governing patient safety.

• Adopts an analytical approach to solve problems relevant to the role.

• Demonstrates an understanding of organizational and planning capabilities by managing own time and resources to complete assigned work.

• Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals.

• Seeks feedback to ensure that verbal and written communications are clear and easy to understand. Keeps management informed of potential issues in a timely manner.

• Works collaboratively with team members.

• Good interpersonal skills and understanding of differing views.

• Trains on the process and tools for the role and receives ongoing coaching and/or mentoring by department peers.

• Excellent written & oral communication skills.

• Ability to work with all levels of the organization, both technical and non-technical.

• Ability to be highly organized, and self-motivated with the capability to prioritize projects and workload.

• Develops and maintains knowledge of cross-functional products, tools, and data sources.

Work Environment/Physical Demands:

• Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

• Travel requirements can be listed by stating up to certain % of time traveling.

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.