Manager, Global Risk Management & Safety Surveillance 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.

The job is based in Wilmington Delaware, US. (Minimum 3 days per week in the office. Local candidates or those willing to relocate only).

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.

Qualifications

Education

• PharmD, MSN (Nurse Practitioner), PA-C, MD, or other relevant healthcare/scientific degree required.
• Recent graduates and candidates completing clinical fellowships, residencies, or advanced training programs are encouraged to apply.
• Oncology Nurse Practitioners, Physician Assistants, and Pharmacists seeking to transition into the pharmaceutical industry are encouraged to apply.
• Willingness to travel (less than 5%) to domestic conferences, as applicable, with reasonable accommodations made for individuals with disabilities.

Experience

• 0-2 years of relevant experience.
• Experience may be gained through clinical practice, fellowship, residency, research, internships, or industry roles.
• Recent graduates, fellows, residents, and early-career professionals are encouraged to apply.
• Prior pharmaceutical, biotechnology, pharmacovigilance, or drug safety experience is beneficial but not required.

Knowledge & Skills

• Strong written and verbal communication skills.
• Interest in drug safety, risk management, pharmacovigilance, and drug development.
• Strong attention to detail and ability to work collaboratively across functions.
• Willingness to learn global pharmacovigilance regulations, safety surveillance activities, and risk management processes.

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.

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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Learn more at: http://www.incyte.com/privacy-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.

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