at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Associate Director, 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 Associate Director, 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. The 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 (ie, 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 (eg, Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Translational & Experimental Medicine, and Legal) and external (eg, regulatory authorities and commercial collaborators) stakeholders.
Serve as proxy for GRMSS Physician.
Other responsibilities, as necessary.sential Functions of the Job (Key responsibilities)
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).
Five 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.
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.
Disclaimer: The above statements are intended to describe the general nature and level of work... For full info follow application link.
We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.