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Job description
Director, Epidemiology - Pharmacovigilance and Risk Management
Full-time
BioPoint, Inc. is a leading global strategic consulting firm that combines deep life sciences industry knowledge with specialized expertise in drug safety, health economics and outcomes research, regulatory affairs, quality assurance, compliance and risk mitigation. Our professionals can and have assisted clients in optimizing their businesses, improving their operations and risk profile, and advancing their organizational performance to seize key opportunities.
Summary:
This position is responsible for all epidemiological aspects of pharmacovigilance and risk management activities for all company products. It provides scientific input in risk evaluation and risk management planning and conducts epidemiological research and projects to further understand any potential risks, and to evaluate effectiveness of risk mitigation strategies after implementation. Analytical and pharmacoepidemiological skills are required, including an understanding of how to analyze customer scientific needs and translate them into outcome-oriented solutions.
Responsibilities
Deliver highly experienced strategic input, epidemiological support and leadership to the pharmacovigilance and risk management teams at all stages of pharmaceutical development, to maximize the benefit-risk profile of company products
Proactively identify, clarify and resolve safety issues from an epidemiologic perspective in collaboration with the pharmacovigilance medical function
Provide timely epidemiologic input into regulatory and risk management reports including PSURs, labeling, Safety Monitoring Plans, REMS/Enhanced Pharmacovigilance Plans and Health Authority, and Expert Statements, Health Authority requests
Provide timely epidemiological and risk management support to project and product teams including design, implementation and analysis of epidemiological studies, review of study proposals from internal and external sources, analyses in adverse events reporting system databases (e.g. AERS, WHO), and interpretation and reporting on data analysis
Maintain knowledge/expertise of existing large databases/data sources and new/emerging epidemiologic methodologies and techniques which may be suitable to conduct epidemiological evaluations
Design, initiate, manage, conduct, analyze, and report on epidemiological research projects in a global environment
Conduct critical appraisal and synthesis of relevant epidemiological literature
Promote good epidemiological/pharmacoepidemiological practice and represent the company's position in any contacts with external experts, collaborative groups or contract research organizations
Qualifications
Ph.D / DSc / DrPH in epidemiology and 3 years postgraduate experience; alternatively, a MSc or MPH with more than 5 years experience
Experience in epidemiological support in pharmaceutical industry preferred
Excellent knowledge in epidemiological methodology and ability to apply it within the pharmaceutical industry at an international level
Ability to perform difficult and specialized scientific investigations and analyses (of a body of literature, data, etc.) with a very high level of thoroughness, attention to detail, and accuracy
Excellent oral and written communication skills
Ability to work effectively in multidisciplinary teams
Ability to critically review the work of other scientists
Ability to learn quickly and become proficient in new domain areas within short time‑frames
Ability to work under minimal supervision on complex projects
Ability to work effectively with external experts, collaborative groups and contract research organizations
Ability to incorporate novel epidemiological techniques into projects
Proficiency in data analysis and interpretation
Thorough and up-to-date technical knowledge of epidemiology and biostatistics methods
Experience and familiarity using SAS for statistical analysis
Record of high quality publications in peer‑reviewed journals
Willingness to travel as needed
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Worksite address
cambridge, MA, 02140, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.