Safety Evidence Generation Lead
Safety Evidence Generation Lead
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Job Description
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets led by VYVGART our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company our partnerships our science and our people because when we do we deliver more for patients.
The Safety Evidence Generation Lead will oversee the transformation of real-world data (RWD) into real-world evidence (RWE) to support argenx therapies with a focus on safety. They will identify evidence gaps develop and execute Integrated Evidence Generation Plans (IEGPs) and lead safety-related studies such as PASS and NIS. Acting as a key safety resource she/he will analyze real-world data monitor product safety and communicate insights to stakeholders. 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
The Safety Evidence Generation Lead will oversee the continuum from real world data (RWD) to real world evidence (RWE). This may include the identification collection integration and evaluation of data from various external sources including claims data electronic health records registries PAS or others.
He/she will 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.
He/she will monitor the safety of our products compare it to any relevant competitor safety profile(s) to understand differentiating aspects and identify evidence gaps in order to optimally contribute to the integrated evidence generation plan (IEGPs).
ROLES AND RESPONSIBILITIES
Monitor the safety of our products in comparison to competitor safety profile(s) to understand differentiating aspects and identify evidence gaps on safety. Utilize analytical methods to interpret real world data support the identification of signals and/or other safety risks 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.
For safety-related PASS or NIS studies take on the leadership in planning and conduct of RWE studies data analyses as well as development of scientific messages and dissemination of data in collaboration with any relevant internal or external stakeholders including vendors.
Oversee safety of all of the participants in PASS studies as well as review all PASS reports (MD only) for inclusion of the correct information that is warranted.
Serve as the primary medical safety resource for all relevant stakeholders in RWE Medical Affairs and other relevant functional areas with respect to evaluation of all factors that may impact safety all safety endpoints and safety data interpretation on real-world studies and data in order to obtain meaningful outcomes in order to support of both products in development as well as those marketed by argenx.
Communicate safety findings 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. Be 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
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. Communicates routinely and clearly with relevant stakeholders and maintains visibility to meet relevant objectives strategies and tactics.
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.
Highly developed analytical skills to understand complex matrix linkages of safety data from various sources.
Embraces innovation by constantly seeking new ways to get results in different situations.
Knowledge of and experienced in conducting studies including PASS NIS and other RWE studies.
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
MD PhD PharmD or similar degree.
Min 10 years working in pharmaceutical/biotech industry:
Strong medical/scientific background inspired by prioritizing patient safety. Good knowledge of pharmaceutical drug development and compound safety generation/monitoring activities.
Good working knowledge of both GCP and GVP.
Experience in RWE generation pharmacoepidemiology and/or rare disease is a plus.
Ability to travel up to 20% of time as needed
At argenx all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
Before you submit your application CV or any other personal details to us please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (argenx) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights please contact our Global Privacy Office by email at .
Employment Type
Full-Time
