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.
PURPOSE OF THE FUNCTION
The Safety Risk Management Lead provides safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development). S/he will perform ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.
ROLES AND RESPONSIBILITIES
* Lead safety signal management activities including data preparations and presentations.
* Assist GPS GSLs in their assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders internally.
* Prepare data for and actively participate in safety governance and risk management processes including safety management teams (SMT) and benefit-risk committees (BRC).
* Effectively lead, oversee and participate in the planning, preparation and review of periodic reports (DSUR, PSUR, PADER).
* Participate in the presentation and analysis of safety data from on-going and completed clinical trials.
* Review and provide safety input, as needed, for key study-related documents, e.g., Investigator's Brochure (IB), Informed Consent Form (ICF), Independent Data Monitoring Committee (IDMC) Charter.
* Participate in protocol development and review, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans, as needed.
* Participate in departmental development activities including SOP and Work Instructions development.
* Perform other activities as needed to assist with departmental activities.
SKILLS AND COMPETENCIES
* Knowledge of pharmacovigilance as applies to safety signal management, safety data review in clinical and post-marketing settings
* Knowledge of relevant global pharmacovigilance regulations and guidelines
* Ability to prepare and/or review high quality safety documents, including periodic aggregate safety reports, signal evaluation report, or risk management plans.
* Ability to communicate complex issues effectively
* Ability to influence and collaborate with multidisciplinary teams
* Ability to prioritize and plan proactively
* Excellent analytical and problem-solving skills, with sound autonomy and applied judgment
* Experience with MedDRA, WHO Drug Dictionary
* Understanding of the principles of databases, querying data sources as well as developing and applying search strategies
* Relevant computer skills including proficiency with Microsoft Office
* Fluency in written and spoken English
EDUCATION, EXPERIENCE AND QUALIFICATIONS
* Bachelor's or Master's degree in pharmacy, nursing, healthcare or other life sciences or technical fields (Ph. D. or M.D a plus)
* Minimum of 7-10 years of relevant pharmaceutical/biotech industry or healthcare experience
* Pharmacovigilance/safety risk management experience is strongly preferred
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.
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