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Senior PV Scientist

Company name
alpha consulting corp.

Hopewell, NJ

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Job Description
SENIOR PV SCIENTISTHOPEWELL, NJ Project Description:Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Appropriately perform core signal detection activities, elevate program or portfolio issues impacting key MST programs, priorities, resources, milestones. Author safety data query responses, contribute to specified sections of the Periodic Benefit Risk Update Report (PBRER) and Development Safety Update Report in a specified therapeutic area and perform core signal detection activities. Ensure pharmacovigilance regulatory compliance with limited or no oversight as needed.Mentor less experienced scientists and teams in aspects of project management, MST requirements, core signal detection, and authoring of safety data query responses and sections of the PBRER and DSUR as appropriate to meet individual or group of MST/subteam needs.\tLead Safety Data Review (SDR) Teams, and participate in related PV and product-development subteam(s) in a specified therapeutic area. Appropriately elevate issues impacting key MST activities, milestones, documents to the MST Chair with limited or no oversight as needed. \tMentor individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs.\tAuthor PV contributions to specified sections of the PBRER and DSURs with limited or no oversight as needed.\tPeriodic review and summary of pertinent safety-related literature, analysis of pre-determined core signal data with limited or no oversight as needed. Provides advice and mentoring to scientists of summaries, evaluations and conclusions.\tAuthor safety data query responses to health authorities including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries with limited or no oversight as needed. Mentor and supervise scientist review and authoring of safety data queries as appropriate.\tCollaborate within and across Client functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required with limited or no oversight as needed. \tApply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Mentor individuals and teams on these applied learnings. Required Skills:\tDegree/Certification/Licensure BS/RN/MS/PharmD/PhD/MD, or equivalent with relevant scientific experience and/or training discipline \tMinimum of 6-9 years BS/RN; 4-6 years MS/PharmD/PhD/MD or equivalent relevant Pharmaceutical Industry experience; demonstrated ability to mentor and coach others.\tGood working understanding of medical concepts and some familiarity with safety activities in drug development and post marketing and global safety health authority requirements. \tGood working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality. \tDemonstrated strong writing skills and experience in authoring and managing the production of strategic scientific documents (e.g., safety-risk related documents, clinical documents, PBRER, DSURs).\tAbility to work well in cross-functional teams.\tStrong collaborative and communication skills with scientific subject matter. \tAttention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (e.g., clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents).\tSoftware that must be used independently and without assistance (e.g., Microsoft Suite) Understand aspects and methods for data analysis, interpretation and presentation. Possess good working skills in MS Word, Excel and PowerPoint, including statistics. This 6 month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: ALPHA'S REQUIREMENT #18-00216MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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alpha consulting corp.
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Company Profile
Our goal, in addition to communicating the benefits of becoming associated with Alpha Consulting, is to provide news, opinions, and resources to assist Clients and Consultants. As with our careers, the content will continuously change and evolve over time. Alpha Consulting Corporation is an IT (Information Technology) staffing firm with the ability to understand your specific project requirements and promptly supply appropriately matched consultants to fill both short and long-term client needs. Solely Focused on IT Staffing Unlike many firms, we do not allow ourselves to become distracted through the pursuit of permanent placement. We do, however, accommodate specific client requests for assistance in identifying qualified permanent employees or negotiating the mutually agreeable conversion of a consultant to a client's permanent staff. We also do not engage in software development, outsourcing, or offshore activities. Our effectiveness is maintained by specializing on our core competency, IT staffing, to the benefit of our clients and consultants. As a small, privately held firm, free from quarterly Wall Street pressure, we have the ability to stay focused on the individual needs of our clients and consultants. Operating from a single location further enables us to concentrate our efforts and provide superior service and support.

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