Principal Safety Data Analysis And Retrieval

Position Title:

Principal Safety Data Analysis and Retrieval

Position Location: MBR/KoP
Business/Functional Unit: Global Clinical Safety and Pharmacovigilance (GCSP)

Approved By: Refer to GDRS
Date: Refer to GDRS SAF_PDN_089 v1.0

Position Purpose: Provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position

The role of Principal Safety Data Analyst sits in the GCSP Data Science team and has global responsibilities pivotal in harnessing patient Safety Data for stakeholders to drive insights from data and decision making. This individual will:

• Apply business analysis skills to interpret, document, and creatively translate complex patient Safety Data challenges into solutions.
• Engage directly with data customer stakeholders within GCSP to grasp their data needs and translate these to other business stakeholders as well as technical teams.
• Be proficient with analysing, prioritizing, managing, and delivering data extraction requests from business stakeholders, querying the GCSP Safety database to meet business needs and regulatory expectations to result in high-quality outputs
• Mitigate risks associated with data retrieval and analysis, ensuring the adoption of best practices.
• Utilize data tools (ie., PowerBI, PV Reports) to unlock and present insights from Safety Data, making complex information accessible to stakeholders.
• Provide support for projects relating to Safety Data Analysis and reporting from inception to delivery
• Participate in vendor oversight, ensuring services are aligned with CSL‘s quality standards and business objectives.
• Mentor and support colleagues and serves as a data subject matter expert in exploring, analysing and introducing new tools, technologies and to increase data literacy and data skills within the GCSP organisation.
• Contribute to business documents including standard procedures, work instructions and work practices to ensure quality control
• Ensure knowledge and compliance with worldwide pharmacovigilance regulations, guidelines and business technology quality standards in a GxP environment for Safety Data retrieval and reporting aspects

Reporting Relationships: List other positions in the company that are reporting into this position or that this position reports into

Roles that this position reports to:

• Head of Data Science

Roles that report to this position: n/a

Main Responsibilities and Accountabilities: List the roles and responsibilities of the position (please limit the number of responsibilities to the primary ten)

1

Customer engagement: Directly engage with data customer stakeholders within GCSP, fully understanding their data needs and effectively communicate these requirements to both business and technical stakeholders. Follow up from problem discovery to solution implementation to ensure the stakeholders needs are met and maintained.

2

Requirement gathering and problem solving: Detail and document business requirements in a manner that adds value to business area experts and the technical teams implementing the solutions. Apply business analysis skills to creatively address and resolve complex patient Safety Data challenges.

3

Data Visualization and Insights: Employ tools such as PowerBI and PV Reports to display Safety Data in the most useable ways, so as to reveal and present safety insights, simplifying complex data for stakeholder comprehension and to enable data-driven decision making.

4

Project support: Provide comprehensive support for business projects requiring Safety Data Analysis and reporting expertise, from their initial conception through to successful delivery. Interacts with and works closely and successfully with Project Management to ensure the solution can feasibly be implemented within the expected budget and timeframes.

5

Vendor oversight: Contribute to understanding business needs for external vendor engagement, detailing vendor requirements, participating in vendor selection and onboarding. Conduct vendor oversight to ensure that services provided meet quality standards, KPIs, and business objectives.

6

Data retrieval and data management: Oversee and ensure timely management and fulfillment of requests from internal GCSP stakeholders, leveraging existing reports where possible and understanding complex pharmacovigilance requirements. Identify and mitigate risks in data retrieval and analysis, advocating for and implementing best practice approaches.

7

PV Domain expertise: Maintain up-to-date knowledge of global pharmacovigilance regulations and guidelines, and ensure compliance within a GxP environment, particularly in aspects of Safety Data standards and Safety Data retrieval and reporting. Serves as subject matter expert for GxP audits & inspections, for relevant data processes and quality aspects.

Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position

Education

Bachelor degree or equivalent in Computer Science, Business systems, or a field related to systems analysis or business analysis is required.

Experience

A minimum of 5 years relevant IT/Business experience including project scoping, Analysis and documentation of business and technical requirements is required. Customer facing experience and vendor oversight experience is highly desired.

Experience in the Pharmaceutical industry is essential. Proven experience of retrieval, analysis, display and output designs of clinical or Safety Data.

Good business process skills and a high understanding of the technologies, tools and systems used throughout.

Competencies

• Strong understanding of Data Analysis and presentation methodologies with an emphasis on deriving actionable insights from patient Safety Data.
• Proficiency in data query and manipulation, with a preference for experience with database management tools and software.
• Experience with business intelligence reporting or visualization tools such as Power BI, with the ability to convey complex data in an accessible format.
• Demonstrated leadership capabilities with potential to assume deputy responsibilities.
• Effective conceptual thinking with the ability to communicate clearly and manage projects in a global team environment.
• Comprehensive knowledge of global pharmacovigilance standards and regulatory requirements, including Good Clinical Practices.
• Highly detail-oriented with a structured approach to working in team-oriented and cross-functional global settings.
• Strong commitment to legal and regulatory compliance, along with quality management principles.
• Understanding of the dynamics and requirements of regulatory inspections and audits.
• Excellent command of English, both verbal and written, for clear, effective communication.
• Accustomed to engaging in and contributing to cross-cultural and cross-functional team settings in a global environment.

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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