Pharmacoepidemiologist, Safety Evidence Generation

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Location Type: Office Salary: [Not Specified] Environmental Conditions: Office

Position Overview

The Pharmacoepidemiologist in the Safety Evidence Generation team will be primarily responsible for generating real-world data (RWD) to support therapies with a focus on safety. This role involves identifying evidence gaps, developing methodology, and overseeing the conduct of real-world studies. The position requires collaboration across functional areas, fostering continuous improvement, and engaging with external stakeholders, including Key Opinion Leaders (KOLs). This role combines medical/scientific expertise, data analytics, and strategic thinking to ensure the safety of our products while maintaining compliance with regulatory standards.

Purpose of the Function

• Design and execute Pharmaco-Epidemiology activities and studies addressing safety research questions in the context of drug development, regulatory submissions, and marketed products.
• Conduct data mining and analyses using various external sources such as claims data, electronic health records, registries, PAS, or others.
• Collaborate with internal and external stakeholders and other decision-makers to lead the planning, design, and contribution to Real-World Evidence (RWE) programs and Integrated Evidence Generation Plans (IEGPs) in support of argenx innovative therapies.
• Collaborate with Safety Evidence Generation Leads and Scientists who supervise the safety of our products and relevant competitor safety profiles, providing insights into differentiating aspects and evidence gaps.

Reporting Line

• Reports to the Head of Safety Evidence Generation.
• Closely collaborates with colleagues in Global and Regional Cross-Functional Teams from Medical Affairs, including RWE, Regulatory, Biostatistics, GPS, Clinical Development, and others as needed.
• Line Management will be through a Thermo Fisher Scientific senior scientist in the PPD™ Evidera™ Real-World Data and Scientific Solutions team.

Roles and Responsibilities

• Study Design and Execution:
  • Design and execute Epidemiology studies addressing safety research questions.
  • Identify epidemiological/pharmaco-epidemiological methods and relevant data sources best suited to address safety research questions.
  • Conduct feasibility studies, design protocols, and prepare statistical analysis plans and reports for pharmacoepidemiologic studies.
• Data Analysis and Interpretation:
  • Transfer epidemiologic expertise and deliverables to the evaluation, refinement, and contextualization of safety findings.
  • Utilize analytical methods to interpret real-world data and support the identification of safety data gaps to generate relevant insights.
• Cross-Functional Collaboration:
  • In collaboration with key functional areas (RWE, Medical Affairs, GPS, Regulatory, HEOR, Clinical Development, Clinical Science), contribute to the development of Integrated Evidence Generation Plans (IEGPs).
  • This includes planning, prioritization, and execution of real-world studies, with a particular focus on safety aspects and outcomes.
• Communication and Stakeholder Engagement:
  • Communicate safety RWD internally and externally promptly with all relevant stakeholders.
  • Collaborate with Scientific Communications on integrated publication plans for safety evidence.
  • Foster continuous learning and improvement with all internal and external stakeholders.
  • Act as an argenx ambassador for engaging with external stakeholders such as KOLs.
  • Attend relevant internal and external meetings for training, competitor intelligence, and collaboration with KOLs and other experts.

Skills and Competencies

• Proven Experience: Demonstrated track record in completing pharmacoepidemiology studies using RWD.
• Analytical Skills: Highly developed analytical skills to understand complex matrix linkages of safety data from various sources.
• Collaboration and Communication:
  • Strong communication, interpersonal, and leadership skills.
  • Proven track record of working and communicating successfully within a complex multi-disciplinary environment.
  • Strong active listening skills with the ability to incorporate input from a variety of internal and external stakeholders.