Department of Pharmacy Practice | Pharmaceutical Fellowship Program
Department of Pharmacy Practice | Pharmaceutical Fellowship Program
Pharmaceutical Fellowship Program

Incyte

Global Risk Management and Safety Surveillance Fellowship*

 

Location: Wilmington, DE
Recruiting: 1 Position for a 1-Year Fellowship

View 2025-2027 Incyte Brochure

Posted September 2024

*New Fellowship

Incyte is a global biopharmaceutical company founded on the premise that investment in strong science and the relentless pursuit of R&D excellence can translate into new solutions that can positively impact the lives of patients. Our research focus spans Oncology and Inflammation & Autoimmunity.

Global Risk Management and Safety Surveillance (GRMSS): GRMSS establishes and maintains an ongoing product safety assessment and risk management system for all products throughout their lifecycle through proactive review, transparent communication, and effective management of product safety risks. GRMSS is responsible for the identification of potential safety issues via continuous individual and aggregate review of safety data, as well as the development of a consistent risk management approach across the global organization.

We invite you to learn more and Solve On.

Global Safety Governance

  • Support GRMSS Physicians by coordinating and leading Safety Management Team meetings at Incyte.
  • Actively participate in risk management safety strategy discussions among Incyte’s internal stakeholders (i.e., Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Translational Sciences, and Legal).

Signal Management

  • Conduct signal management, which includes the following activities: detection, validation, prioritization, confirmation, documentation, recommendation for action, and communication.
  • Ensure that signals are communicated to relevant parties, as appropriate.

Reference Safety Information

  • Liaise with GRMSS Physicians in the evaluation of safety data to compile the reference safety information for Incyte products, included in the Investigator Brochures, Company Core Data Sheets, and regional labels.
  • As a core member of the labeling team, collaborate with GRMSS Physicians, Regulatory Affairs, and Clinical Development to support the various safety sections of product labels (i.e. Warnings and Precautions, Adverse Reactions, and Contraindications).

Aggregate Safety Reports

  • Liaise with GRMSS Physicians and Scientists in the preparation, drafting, and finalization of aggregate safety reports (i.e., Development Safety Update Reports [DSURs], Periodic Benefit-Risk Evaluation Reports [PBRERs], Periodic Adverse Drug Experience Reports [PADERs]) for Incyte clinical trial programs and marketed products.

Risk Management Plans

  • Actively participate in the preparation of initial risk management plans and subsequent updates throughout the lifecycle of Incyte’s marketed medicinal products.

Additional Experience

  • Formulate clinical trial and post-marketing risk management safety strategies.
  • Contribute to the review and strategy of integrated summaries of safety, clinical overviews, and other registration documents in collaboration with GRMSS Physicians, Clinical Development, Medical Writing, Biostatistics, and Regulatory Affairs.
  • Contribute to preparedness for regulatory authority inspection and internal audits of Incyte’s Global Pharmacovigilance and Risk Management department.
  • Rotate across the various groups within Global Pharmacovigilance and Risk Management (e.g. PhV Operations, Portfolio Management), as well as gain exposure to other functional areas based on individual interest.

 

Executive Sponsors

Debbie Kelly, MD; Division Vice President, Global Pharmacovigilance & Risk Management

“We are delighted to welcome a Fellow to participate as a valuable member of our Global Risk Management and Safety Surveillance team to gain technical pharmacovigilance skills through first-hand experiences in global drug safety activities. 

Incyte’s extensive development and marketed product portfolios will provide exposure to and education in global safety reporting regulations, safety data review, signal management activities, aggregate safety reporting, and risk management activities to manage, mitigate, and minimize adverse effects. These activities will support ensuring a positive benefit-risk profile for study participants and patients treated with Incyte products. 

We are excited to help educate and develop the next generation of drug safety experts to ensure that patient safety is the foundation of potential career opportunities in pharmacovigilance or more broadly in the biopharmaceutical industry.”

 

Program Leadership and Preceptors 

Caitlin Cahayla, PharmD; Senior Manager, GRMSS Scientist

Mike Campbell, RN, BS, MBA; Associate Vice President, GRMSS Science

Kathy Roberts, MS; Vice President, Global Pharmacovigilance

Tina Nguyen, PharmD; Associate Director, GRMSS Scientist

Jennifer Rocheleau, MSN, CRNP, ANP-BC; Associate Director, GRMSS Scientist