Director, Epidemiology - Pharmacovigilance and Risk Management

Company Description

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, improve their operations and risk profile, and advance their organizational performance to seize key opportunities.

Job Description

Summary:

This position is responsible for all epidemiological aspects of pharmacovigilance and risk management activities for all company products. This position provides scientific input in risk evaluation and risk management planning and conducts epidemiological research and projects to further understand any potential risks, as well as 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
• Proactive 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 proposal from internal and external sources, analyses in adverse events reporting system databases (e.g. AERS, WHO), and interpretation and reporting on data analysis
• Maintains knowledge/expertise of existing large databases/data sources and new/emerging epidemiologic methodologies and techniques which may be suitable to conduct epidemiological evaluations
• Design, initiation, management, conduct, analysis, and reporting of 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

Competencies:

• 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

Additional Information

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