Overview A global biopharmaceutical company on a mission to Solve On Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery development and commercialization of proprietary therapeutics Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology Oncology and Inflammation and Autoimmunity Headquartered in Wilmington Delaware Incyte has operations in North America Europe and Asia. Job Summary Primary function This Global Risk Management & Safety Surveillance GRMSS Scientist collaborates with the GRMSS Physician to characterize the evolving clinical and post-marketing safety profiles for Incyte investigational drugs andor products based on analysis of aggregate data sets from internal or external sources and the medical literature. This entails drafting reviewing and refining portions of periodic aggregate safety reports including DSURs RMPs and PBRERs IBRSI updates safety-related product label updates and responses to health authority requests for information. The GRMSS Scientist performs the signal detection activities and review process for clinical and post-marketing data including signal detection evaluation and verification potential sources of data for signal detection include Incyte external marketing partners or contracted business entities. The Scientist in this position documents signal detection activities and communicates appropriate summaries to internal stakeholders and external partners. Essential Functions of the Job Key responsibilities Provide overall support to the GRMSS Physicians for global risk management and safety surveillance activities. Supportcontribute to the discussions on risk management safety strategies to internal stakeholders e.g. Clinical Development Medical Affairs Regulatory Affairs Quality Assurance Commercial Translational & Experimental Medicine and Legal. Contribute to preparedness for regulatory authority inspection and internal audits of Incyte Pharmacovigilance by following standard operation procedures and processes. Participate in internal safety process improvements and updates. Support the GRMSS Physician in evaluating safety data to compile reference safety information for Incyte products included in the Investigator Brochures Core Data Sheets and regional labels. Participate in the review of integrated summaries of safety clinical overviews and other registration documents e.g. for new and supplemental NDAs andor ex-US new drug submissions for late-phase drug development candidates and marketed products in collaboration with the GRMSS team including professionals from Clinical Development Medical Writing Statistics and Regulatory Affairs. In collaboration with the GRMSS PhysicianScientist support the preparation of Aggregate Reports DSURs PSURS PADERS etc. for Incyte clinical trial programs and marketed products. Provide support as needed to the GRMSS Physician in reviewing periodic literature for new and important information regarding Incyte products. Support the GRMSS PhysicianScientist in the preparation of initial Risk Management Plans RMPs and subsequent updates throughout the lifecycle of a medicinal product. Perform drug signal management activities including the drafting of signal evaluation reports for Incytes portfolio of investigational and marketed products. Collaborate with GRMSS Physician in the development of clinical trial and post-marketing risk management safety strategies. Support GRMSS Medical Professional and coordinatelead Safety Management Team meetings. Qualifications Minimal acceptable level of education work experience and competency Experience in pharmacovigilance relating to oncologic or inflammatory diseases or relating to clinical support of oncology immunomodulatory or other related products is preferred but not required. We welcome candidates with diverse experiences and backgrounds. Experience in pharmaceutical industry activities involving international health authorities is preferred. Proficiency in written and spoken English or other relevant languages. Experience incorporating safety findings into reference safety information preferred. Experience analyzing case reports for the purposes of preparing aggregate safety reports signal detection and evaluation labeling changes and responding to queries by regulatory authorities is valued. Experience in the pharmaceuticalbiotechnology industry is valued but not required. We welcome candidates with diverse backgrounds and experiences. Relevant scientific degree or equivalent experience in healthcare preferred. Willingness to travel less than 5 to domestic conferences as applicable with reasonable accommodations made for individuals with disabilities. Disclaimer The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties responsibilities and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at httpwww.incyte.comprivacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access delete restrict edit move or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incytes data protection practices here. By accessing this link you can learn about the types of personal data we collect how we use it whether collection and processing is optional sources of the personal data we process how it is shared where it is stored or transferred to how long we keep it and contact information for Incyte Incytes data protection officer and your supervisory authority if applicable. Please contact privacyincyte.com if you have any questions or concerns or would like to exercise your rights.