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Manager/Sr. Manager, Global Risk Management & Safety Surveillance Scientist Wilmington United States,  

Posted on : 07 May 2017

Project Description

This position is responsible for supporting 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 as well as the medical literature. This entails drafting, reviewing, and refining portions of periodic safety reports (including PADER, PBRER, DSUR, , RMP), IB updates, USPI revisions, international product labels and core data sheets, and ad hoc health authority requests for information. This position is responsible for the signal detection activities and 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. This position is responsible for documentation of signal detection activities and communication of appropriate summaries to internal stakeholders and external partners. The position will also support future risk management activities for Incyte products. This position reports to the Medical Director, Global Risk Management and Safety Surveillance (RMSS Physician).   Job Responsibilities:   Support RMSS Physician, coordinate Safety Management Team and manage all safety risk management activities for assigned product Prepare local and global risk management plans and ensure their execution throughout a medicinal product?s lifecycle Formulate clinical trial and post marketing risk management safety strategies that are in alignment with the company's drug development and commercialization strategies Perform drug safety signal detection activities including the drafting of signal evaluation reports for Incyte?s portfolio of development and marketed products Author first round drafts of all ad hoc and scheduled safety evaluations Drive kick-off meetings for risk management collaborations Review periodic literature surveys of new and important information regarding Incyte products, as well as relevant products from collaboration partners, potentially impacting human safety, both in conjunction with external collaboration partners and independently within Incyte Under the direction of the RMSS Physician, drive preparation DSURs for Incyte clinical trial programs, and PADERs and/or PBRERs for marketed products Perform first round input on and review of integrated summaries of safety, clinical overviews, and other registration documents for new and supplemental NDAs and/or ex-US new drug submissions for late-phase drug development candidates and marketed products in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs Execute agreed-upon safety strategy for Reference Safety Information for Incyte products, including Investigator Brochures and new or updated labeling (USPI or CDS) 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, including new means of effective presentation of early phase clinical study status reports with regard to safety findings Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance, and contribute to the development and implementation of any preventative and/or corrective action plans as they pertain to specific identified deficiencies of policy, procedure, or practice in RMSS Champion risk management safety strategy to internal (eg, Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Translational & Experimental Medicine and Legal) and external stakeholders (eg, regulators and commercial collaborators) Serve as proxy for RMSS Physician and performs other duties as required   Minimum Requirements:  Nursing, Ph.D. or Pharm.D. degree (or equivalent industry experience) >5 years total pharmaceutical/biotechnology industry experience, of which >2 years will have been in a drug safety or pharmacovigilance role Experience analyzing case series 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    Highly Preferable (but not an absolute requirement):   M.P.H. or relevant epidemiology experience in industry or academia Experience in pharmaceutical industry activities involving health authorities outside the United States Experience in pharmacovigilance relating to oncology or inflammatory diseases, or clinical support of oncology, immunomodulatory, or other related products


Wilmington DE

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