Manager, GRMSS Safety Scientist

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 and/or 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), IB/RSI 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.
• Support/contribute 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 and/or 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 Physician/Scientist, 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 Physician/Scientist 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 Incyte's 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 coordinate/lead 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 pharmaceutical/biotechnology 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.

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