Product Vigilance Scientist II

Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity for a Product Vigilance Scientist II with one of our top clients in Fort Washington, PA.

This a 6 month assignment. Product Vigilance Scientist II JOB RESPONSABILITIES: Description The Senior Product Risk Management Scientist SPRMS is a senior level position reporting to the Senior Director, Medical Safety Officer. The SPRMS is responsible for the review and analysis of any safety-associated issues that are or might be due to product quality or manufacturing issues, for the analysis of safety surveillance observations, and for the response to safety inquiries from the Medical Safety Officer and internal and external authorities using post-marketing databases including AERS and MAUDE, the medical literature and exposure information for a wide range of OTC, Consumer Medical Devices and Personal Consumer products. The SPRMS will work directly and cross-functionally with product development teams, quality assurance teams and post-marketing PV groups. The SPRMS will report analysis results in support of or resolution of signal detection surveillance, develop health hazard / risk evaluations for drug, device and cosmetic products, create risk management plans, be responsible for compiling regulatory submissions, label justifications, and the medical assessment of safety profiles for all products in assigned franchises. In this role, the SPRMS has a responsibility and accountability for the compliance, quality and technical content of surveillance, aggregate and ad-hoc safety assessment reports. In addition, the SPVS may be expected to develop content of Risk Management Plans for technical documents; summarize ongoing project-related safety issues for presentation to the Global Safety Committee; create project or existing product summaries for regulatory submission documentation purposes; and, may assist in the management of safety issues from development through post-marketing. Tasks and activities of the SPRMS in the assessment, strategy and management of product safety include, but are not limited to: Contributes to safety report strategy and planning | Directs and/or Initiates searches of post-marketing databases and related product vigilance sources, customer response systems and Health Authority databases | Conducts or directs searches of medical textbooks, reference sources e.g. USP, CDC, AERS, MAUDE , and scientific literature | Analyzes and interprets aggregate / tabulated safety surveillance data, lot trend and exposure information | Identifies the need for, conducts and summarizes case series reviews | Prepares, drafts, edits and /or writes scheduled and ad-hoc regulatory and aggregate reports, labeling, core data sheet updates and related documents | Prepares, compiles and drafts safety documentation used in medical safety assessments, health hazard / risk evaluations, risk management plans, safety responses and other regulatory submissions | Evaluates and summarizes product efficacy data used in risk management plans or related documents | Represents the Medical Safety Officer as a participant in quality and safety committees to assist in safety issue management and signal escalation.