Pharmacoepidemiologist in Safety Evidence Generation - Client Dedicated

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

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. They will identify evidence gaps, develop methodology, and oversee the conduct of real-world studies. This role involves 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. This will include 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 any other contribution(s) to RWE programs and 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 profile(s), and who provide insights into differentiating aspects, and evidence gaps.

REPORTING LINE

• Will report to the Head of Safety Evidence Generation and will closely collaborate 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

• Design and execute Epidemiology studies addressing safety research questions.
• Identify epidemiological / pharmaco-epidemiological methods, relevant data sources, best suited to address safety research questions. This includes but is not limited to conducting the feasibility, designing, preparing study concepts, protocols, and statistical analysis plans, and report of pharmacoepidemiologic studies.
• Transfer epidemiologic expertise and deliverables to the evaluation, refinement and contextualization of safety findings. Utilize analytical methods to interpret real world data, support the identification of safety data gaps in order to generate relevant insights.
• 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), including the planning, prioritization, and execution of real-world studies, with particular focus on safety aspects and outcomes.
• Communicate safety RWD internally and externally promptly with all relevant stakeholders. Collaborate with Scientific Communications on integrated publication plans for safety evidence.
• Foster a continuous learning/improvement with all internal/external stakeholders.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 including a track record in completing pharmacoepidemiology studies using RWD.
• Highly developed analytical skills to understand complex matrix linkages of safety data from various sources.
• Collaborative with strong communication, interpersonal, and leadership skills and a proven track record of working and communication successfully within a complex multi-disciplinary environment.
• Strong active listening skills with ability to incorporate input from a variety of internal and external stakeholders.
• Drives initiative with ability to work with minimal supervision.
• Good organizational skills and “hands on” attitude, reliable and solution oriented.
• Effective in setting clear priorities among competing activities. Leverages' experience and know-how to focus on priority objectives.
• Embraces innovation by constantly seeking new ways to get results in different situations.
• Proactively evaluates and participates in ongoing professional development opportunities in order to leverage the best in class approaches to real world data evidence generation.
• EDUCATION, EXPERIENCE AND QUALIFICATIONS
• Background in health and life sciences (epidemiology, public health, MD, pharm D), or quantitative data sciences, biostatistics
• PhD in Epidemiology and/or pharmacoepidemiology or equivalent advantageous
• At least 5-year experience in epidemiology/ pharmacoepidemiology as well as in drug safety
• Excellent written and oral communication skills in English
• Strong medical/scientific background, inspired by prioritizing patient safety.
• Solid understanding of both GCP and GVP.
• Substantial prior experience of working with RWE/D within the pharmaceutical industry, particularly in the application of RWE in drug development for rare indications is a plus
• Ability to travel up to 20% of time as needed

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