Job Overview
Provide strategic statistical and epidemiological research, review, and evaluation support to Lifecycle Safety’s Benefit-Risk Management Services.
Essential Functions
• Actively contribute to launching a new service offering, Benefit-Risk Management (BRM), into the marketplace and developing the customer base.
• Provide strategic statistical and epidemiological research input to Lifecycle Safety’s BRM initiative to help increase revenue, with emphasis on methods to cut costs, decrease time, or increase chance of product commercial success through appropriate management of risk and benefit determination.
• Lead integration of IQVIA’ vast safety expertise for developing optimal customer solutions across functional units.
• Provide strategic BRM analysis and consultancy to customers on a billable basis.
• Maintain knowledge and awareness of developments in biostatistics, epidemiology and safety. Carry out new developments in areas of statistical design or analysis that can be used to give IQVIA a greater edge over competing CROs.
• Market IQVIA’ BRM expertise, may include:(i) publishing papers that demonstrate expertise in key areas (such as risk management and BRM analysis)
• (ii) giving presentations at conferences, particularly those attended by key decision makers for outsourcing high value business
• and (iv) contribute to publicizing internally to key groups.
• Actively network in the industry to establish relationships and to identify potential opportunities.
• Deliver/oversee billable services to customers aligned with domain expertise. Design and lead client engagements and oversee project deliverables including BRM analysis plans, progress reports, presentations, abstracts, manuscripts and product dossiers.
• Lead and participate in the provision of training to internal IQVIA staff.
Qualifications
• Epidemiology, Biostatistics or other related scientific discipline with 10 years’ experience in
pharmacovigilance or pharmacoepidemiology in a consulting, industry, or Federal setting
• Epidemiology or closely-related discipline with 3 yrs’ CRO/consulting, pharmaceutical, risk management and registry experience.; or equivalent combination of education, training and experience
•
• Extensive and in-depth knowledge of many of those complex statistical analysis methods that apply to risk management, pharmacoepidemiology, and clinical trials.
• Good overview knowledge of many of the new and cutting-edge design and analytical approaches that can beneficially be applied to all phases of clinical trials and risk management strategies.
• Ability to strategically identify and implement optimal risk management solutions.
• Moderately high level of knowledge of current guidelines with respect to risk management during drug development and post-marketing.
• Good understanding of peri- and post-approval risk management needs.
• Thorough knowledge of global risk management requirements with an emphasis on US and EU regulations and developing trends.
• Knowledge of SAS.
• Ability to quickly learn risk management and signal detection electronic tools.
• Excellent written and oral communication skills.
• Strong negotiating skills.
• Ability to operate simultaneously across numerous projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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