The Drive to Discover. The Experience to Deliver.

Careers At Incyte Corporation

Looking for a challenge and a chance to grow your career?

Then Incyte is the pharmaceutical company for you. While our pipeline demonstrates the ability to compete with much larger pharmaceutical companies in selecting compelling targets and creating high-quality drug candidates, our smaller size enables employees to see the direct impact of their contributions on the direction of the company. Due to our smart, agile culture and cutting-edge science, we delivered a novel, first-to-market product in an unmet medical need in 2011 - the first in the company's history.

Opportunities for taking on new and/or additional responsibilities, in addition to advancement, are a key element in our culture. Add to that a science-based, fast-paced work environment and you’ve got an exciting company in which to work.

In addition to opportunities for growth, we offer an outstanding benefits andcompensation package to help meet personal needs as well.

Take a look at our current openings to find the match that’s right for you!

Incyte Corporation values the talents of our diverse workforce and is proud to be an Equal Opportunity Employer.


Manager/Senior Manager to Associate Director/Director, GRMSS Scientist

Department: Pharmacovigilance
Location: Incyte Corporate Headquarters

Manager/Sr. Manager to Associate Director/Director, GRMSS Scientist

Job Summary  (Primary function)
This Global Risk Management & Safety Surveillance (GRMSS) Scientist collaborates with the GRMSS Physician to characterize the evolving clinical and postmarketing 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 postmarketing data, including signal detection, evaluation, and verification; potential sources of data for signal detection include Incyte, external marketing partners, or contracted business entities.  This Scientist in this position documents signal detection activities and communicates appropriate summaries to internal stakeholders and external partners.  The incumbent reports to the GRMSS Scientist Lead.

Essential Functions of the Job  (Key responsibilities)

•      Support GRMSS Physician and coordinate Safety Governance Team meetings.

•      Formulate clinical trial and postmarketing risk management safety strategies.

•      Perform drug signal management activities, including the drafting of signal evaluation reports for Incyte’s portfolio of investigational and marketed products.

•      Prepare RMPs and ensure their execution throughout the lifecycle of a medicinal product.

•      Author first-round drafts of all ad hoc and scheduled safety evaluations.

•      Review periodic literature for new and important information regarding Incyte products.

•      Under the direction of the GRMSS Physician, drive preparation of DSURs for Incyte clinical trial programs, and PBRERs for marketed products.

•      Participate in the review of integrated summaries of safety, clinical overviews, and other registration documents (i.e., for new and supplemental NDAs and/or ex-US new drug submissions for late-phase drug development candidates and marketed products) in collaboration with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs.

•      Evaluate data and compile the RSI for Incyte products, including IBs and new or updated labeling, for marketed products in the context of multidisciplinary groups within Incyte or joint committees between external partners.

•      Participate in internal safety process improvements and updates.

•      Contribute to preparedness for regulatory authority inspection and internal audits of Incyte Pharmacovigilance; contribute to the development and implementation of any preventative and/or corrective action plans as they pertain to specific deficiencies of policy, procedure, or practice in GRMSS.

•      Champion risk management safety strategy to internal (e.g., Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Translational & Experimental Medicine and Legal) and external (e.g., regulatory authorities and commercial collaborators) stakeholders.

•      Serve as proxy for GRMSS Physician.

•      Other responsibilities, as required. 

Qualifications (Minimal acceptable level of education, work experience, and competency)

•      Nursing, Ph.D. or Pharm.D. degree (or relevant scientific degree buttressed by industry experience).

•       Experience requirements vary by position:  

Manager, GRMSS Scientist - Approximately 1 to 2 years total pharmaceutical/biotechnology industry experience, of which 1 year will have been in a drug safety or pharmacovigilance role; Sr Manager, GRMSS Scientist - Approximately 3 to 5 years total of pharmaceutical/biotechnology industry experience, of which more than 3 years will have been in a drug safety or pharmacovigilance role; Associate Director, GRMSS Scientist – 5 to 10 years total of pharmaceutical/biotechnology industry experience, of which more than 5 years will have been in a drug safety or pharmacovigilance role; Director, GRMSS Scientist – Ten or more years of pharmaceutical/biotechnology industry experience, of which more than 8 years will have been in a drug safety or pharmacovigilance role.

•      Experience analyzing case reports for the purposes of aggregate safety reporting, signal detection and evaluation, issue management, labeling changes, and responding to queries by regulatory authorities.

•      Experience incorporating safety findings into Reference Safety Information (USPI, CDS, IB, etc.).

•      Fluency in written and spoken English.

•      Experience in pharmaceutical industry activities involving health authorities outside the United States preferred.

•      Experience in pharmacovigilance relating to oncologic or inflammatory diseases, or relating to clinical support of oncology, immunomodulatory, or other related products preferred.

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.

 

Applicant Tracking System Powered by ClearCompany HRM Applicant Tracking System