PCP Pharmaceutical Industry & Education Fellow: Incyte – Global Risk Management and Safety Surveillance (1 year)

Position Title:

PCP Pharmaceutical Industry & Education Fellow: Incyte – Global Risk Management and Safety Surveillance (1 year)

Time Type:

Full time

Position Summary And Qualifications:

This is a 1-year post-graduate training program providing advanced skill training in a variety of functions within 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 at Incyte.

This fellowship prepares individuals to pursue a career in the pharmaceutical industry.

Weekly responsibilities are split between Saint Joseph’s University (20%) and Incyte (80%).

The fellow will successfully complete projects related to industry, the fellowship program, and teaching responsibilities.

It is expected that as the fellow progresses through the program, the individual will be able to practice with increasing levels of independence.

Note - About Uploads

All applicants should include the ALL of following attachments into the "Resume/CV" field of their application: a letter of intent; a curriculum vitae; unofficial college transcripts, both undergrad and professional; a document listing (3) references with their name, degree(s), title, email address and phone number for each reference; and a writing sample (e.g., example of drug information response; other non-peer reviewed materials are acceptable. No posters, slide presentations, group activities, or peer reviewed publications). The online application system only allows for 5 total attachments, please consider this as you upload your attachments.

Fellowship Objectives

• Develop and cultivate core skills and competencies in analytical reasoning, critical and strategic thinking, problem solving, communication, influencing, and teamwork.
• Develop professional responsibility and enhance leadership presence.
• Enhance interpersonal communications with healthcare providers, strategic business partners, and consumers.
• Strengthen ability to critically evaluate, interpret, synthesize, and communicate scientific information.
• Instill knowledge of laws, compliance regulations, and guidance’s pertaining to medical and regulatory affairs
• Advance critical thinking skills through industry-based projects and cross-functional teamwork. 
• Strengthen leadership and professionalism through participation in academic and industry initiatives.
• Apply and communicate clinical knowledge to projects and project teams.

Essential Duties & Responsibilities

Industry-Based Responsibilities:

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.

University-Based Responsibilities:

• Completion of a one-year teaching certificate program with responsibilities for didactic and experiential teaching and a continuing education (CE) presentation for pharmacists
• Actively participate in professional development seminars and workshops designed to enhance professional growth and leadership
• Contribute to the successful functioning of the fellowship program, such as facilitating student outreach, recruitment, marketing, social media, team building, etc.

Secondary Duties & Responsibilities

As a training program, all the duties and responsibilities are considered primary and necessary for successful completion of the fellowship.

Minimum Qualifications

Required:

• Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy (by the start of the fellowship program) OR a PhD in a relevant scientific/life sciences field (e.g., immunology, pharmacology, cancer biology.)
• It is expected that the fellow will be able to commute to both the university and the company to fulfill fellowship requirements.

Preferred:

• Computer skills: Microsoft Office, email and calendar proficiency
• Sufficient technology aptitude to learn new technology systems, including virtual conferencing if necessary
• Medical writing proficiency
• Communication skills, including formal presentations
• Ability to work cross-functionally with a diverse team

Physical Requirements

This position does not require lifting or pulling as part of the day-to-day activities.

Unusual Work Hours

• Throughout the year, there will be periodic times when the fellow will be responsible for attending conferences, webinars or meetings outside the usual work hours, either in the evenings or on the weekends.
• Travel may be required to represent the fellowship at various recruitment sessions, such as university career fairs and professional conferences.
• The fellow will be required to split their time between the university and the industry site.

Required Documents: See Note At The Top Of This Posting

• Curriculum vitae / resume
• Letter of intent
• Example of drug information response (other non-peer reviewed material is acceptable)
• Unofficial transcript(s)
• Contact information for 3 references

Saint Joseph’s University is a private, Catholic, Jesuit institution and we expect members of our community to be knowledgeable about – and to make a positive contribution to – our mission. Saint Joseph’s University is an equal opportunity employer that seeks to recruit, develop and retain a talented and diverse workforce. The University is committed to the diversity of its faculty and staff so that our students, our disciplines and our community as a whole can benefit from the multiple perspectives it offers. The University seeks qualified candidates who share our commitment to equity, diversity and inclusion. EOE

Saint Joseph’s University prohibits discrimination on the basis of sex in its programs and activities, including admission and employment, in accordance with Title IX of the Education Amendments of 1972. The Title IX Coordinator is responsible for overseeing compliance with Title IX and other civil rights laws and regulations. To contact the Title IX Coordinator, e-mail titleix@sju.edu, visit Campion Student Center suite 243, or call 610-660-1145. To learn more about the University’s Title IX policies, the process for filing a report or formal complaint of sex discrimination, sexual harassment, or other form of sexual misconduct, and the University’s response to reports and/or formal complaints, please visit www.sju.edu/titleix. Inquiries may also be directed to the Federal agency responsible for enforcing Title IX, the U.S. Department of Education Office for Civil Rights.

Pay Transparency & Benefits Overview

Please click to read more about the university's approach to pay and benefits transparency. Adjunct instructor compensation can be found in the article. Otherwise, an estimated pay range is listed below. This position's estimated pay range is:

$61,800.00 - $74,100.00