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9 Dec 2020

Temporary Pharmacovigilance (PV) Scientist (20-19811)

Axelon Services Corporation – Posted by iris.chen@axelon.com Summit, New Jersey, United States

Job Description

Job Description: Responsibilities:

• Understand that Client and Client are still integrating the safety department and the Safety Science team.
Working knowledge of post-marketing signal detection activities
Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s). Appropriately elevate signal detection findings impacting key Safety Management Team (SMT) activities, milestones, and documents to the Safety Physician Chair. Support individuals in aspects of project management, drug development and SMT requirements, as appropriate to meet overall SMT/subteam needs.
• Provides support to the Safety Physician in activities relating to monitoring and management of Product’s emerging safety profile
• May contribute to preparation of materials (Slides, etc.) in preparation of Safety Management Team or company safety committee meetings
• Obtains integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the lead product safety physician for a compound
• May support the lead product safety physician with the management of the product’s benefit/risk profile
• Author and contribute to specified PV sections of the investigator brochure, reference safety information, PBRERs and DSURs with oversight, as needed
• Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to safety data/ad hoc queries and HA requests.
• Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
• Collaborate within and across Client functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
• Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.

Requirements:
• Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience

At least 4-6 years of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required.

Working understanding of HEMATOLOGY and cancer medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.

• 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.
• Ability to work well in cross-functional teams.
• Good collaborative and communication skills with scientific subject matter.
• Attention 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 (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents).
• Understand aspects and methods for data analysis, interpretation and presentation.
• Possess good working skills in MS Word, Excel and PowerPoint, including statistics

How to Apply

Please send your updated resume to iris.chen@axelon.com

Job Types: Temporary.

Job expires in 46 days.

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