Location:
Northbrook, IL
Posted Date:
5/21/2012
Position Type:
BS FULL TIME
Job Code:
2000011705210
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Description
Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us!Astellas is announcing a Associate Director, Pharmacoepidemiology opportunity in our Deerfield, IL location.The Assistant Director, Pharmacoepidemiology (PE) is responsible for:Serving as Pharmacoepidemiology Lead on one or more global Therapeutic Area Pharmacovigilance Teams with responsibility for crafting Pharmacoepidemiology strategy for multiple drugs in development and on the market;Generating innovative database study designs to answer critical safety questions, executing such studies, analyzing the results, and authoring analytical reports and position papers based on the findings;Leading global teams to develop new Pharmacoepidemiology and safety surveillance processes, systems, and tools;Impact:Answers regulatory inquiries through analysis of internal and external databases;Meets REMS and RMP commitments to regulators that are required for ongoing marketing approval;Provides analytical insights for critical safety decisions;Delivers new processes and tools that improve the company's safety surveillance and risk management systems.Collaborate with other members of one or more Therapeutic Area (TA) Pharmacovigilance Teams to develop and implement global PE analytical strategies and conduct database studies of internal and external data in support of TA goals and objectives.In collaboration internal and external cross-functional stakeholders (Clinical, Regulatory, Biostatistics, etc.) to design, develop and execute PE studies which will provide in support of risk management plans. Provides leadership and oversight for the development and execution of project timelines and deliverables.Advices and provides consultation to Global Development Operations in the planning of clinical trials by providing epidemiologic expertise concerning specific population or disease characteristics.Collect, analyze and communicate PE data (such as incidence;/prevalence estimates, natural history of disease data) to Pharmacovigilance and Clinical Teams to support analyses and interpretation of safety data gathered from internal and external sourcesProvide leadership to PSP in identification and implementation of new technologies and processes for safety surveillance and risk management (for example the ASSET project).Collaborate with Risk Management to develop and manage product specific pre- and post-approval PE riskmanagement strategiesDevelop and implement new methodologies and standards, and appropriately utilize pharmacoepidemiologic tools for the identification and analysis of potential safety signals.Assist in the development of SOPs and Working Procedures in the PE area.
Requirements
EducationMPH or PhD in Epidemiology, Health Services Research, or related field.ExperienceEpidemiology or Pharmacoepidemiology working experience (7+ years with master's degree and 5+ with PhD)Pharmaceutical industry experience (3+ years)Project management experience (2+ years)Principal author/co-author of in-house and external scientific publications.KnowledgeDemonstrated expertise in utilizing pharmacoepidemiology principles, methodologies, and databases for pharmacovigilance projectsIn-depth knowledge of Clinical Development and Pharmacovigilance business processes,Solid understanding of US and ex-US safety regulationsDemonstrated experience in analytical study design and methodologiesSkillsBasic understanding of SAS or other statistical analysis software toolsAdvanced scientific writing skillsEnglish language fluencyAdvanced proficiency of Microsoft office tools including Word, PowerPoint, and ExcelPersonal AttributesStrategic perspectiveCustomer service orientationCommitment to meeting agreed goalsInter-personal communication*cb
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