Benefit Risk Management Analyst

Job Overview
Provide technical writing, research support, and benefit-risk analysis for key benefit-risk management (BRM) deliverables such as Risk Management Plans (EU-RMPs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Risk Evaluation and Mitigation Strategies (REMS), and signal detection reports

Essential Functions
• Contribute the pharmacovigilance and benefit-risk perspectives and content to the writing of EU-RMPs, PBRERs, REMS, signal detection reports, and other BRM deliverables using pharmacoepidemiology skills and scientific knowledge
• Identify, obtain, and synthesize information and data for creation of BRM deliverables (i.e., search and extraction of key figures from existing documents, in-depth literature reviews, internet searches, descriptive data analysis, etc).
• Utilize available in-house databases (e.g., IQVIA SMART) and signal detection tools (e.g., Oracle Argus, Empirica Signal, etc.) to contribute to BRM deliverables
• Contribute to overall safety knowledge and methods for routine regulatory submissions and other related activities.
• Seek and provide in-house training, as necessary, to fulfill responsibilities

Qualifications
• Life science discipline with 7 years’ experience
• Epidemiology with 4 years’ experience; or equivalent combination of education, training and experience
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• Ability to assimilate large volumes of scientific information and summarize them for the completion of BRM deliverables.
• Ability to identify and describe optimal risk management solutions and evaluate risk management programs.
• Knowledge of current guidelines with respect to risk management requirements during drug development and post-marketing (e.g., EMA GVP guidance, FDA guidance for industry, etc).
• Ability to quickly learn risk management and signal detection electronic tools.
• Excellent written and oral communication skills.
• Ability to operate simultaneously across several projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to effectively communicate and collaborate in a team environment.
• Excellent oral and written communication skills [including the ability/skill to summarize large amounts of scientific information].  Ability to adjust to changing priorities and excellent organizational and time management skills.
• Outstanding attention to detail.
• Flexible, resourceful, and willing to help wherever needed.
• Proficiency in commonly used office computing software and reference management software.