Associate Consultant – Pharmacoepidemiologist Job Vacancy in Eli Lilly Bengaluru, Karnataka – Latest Jobs in Bengaluru, Karnataka
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Company Name : Eli Lilly
Location : Bengaluru, Karnataka
Position :
Job Description : At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
KEY RESPONSIBILITIES
Global Patient Safety Support
Act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to epidemiology; and provide pharmacoepidemiology support.
Demonstrate understanding of the roles and responsibility of the EU QPPV.
Support audit readiness.
Support Risk Management Planning
Provide epidemiology expertise to support compounds in development, new product launches, and existing marketed products.
Partner/collaborate with Medical Affairs physicians and scientists and Safety Medical physicians and scientists on risk management plans.
Design, conduct, analyze and interpret pharmacoepidemiology studies using appropriate methods and data sources
Work with external investigators and Contract Research Organizations (CROs)
Review and develop study protocols
Address safety-related questions based on population-based health statistics and electronic health information databases (e.g., administrative claims databases, electronic medical records).
Characterize Natural History of Diseases
Provide support to Development and Medical Affairs and Safety Medical with epidemiological data from the literature or other relevant data sources to understand the nature history and burden of disease/conditions for which the Company is developing new products to treat or to prevent
Conduct and manage epidemiology studies to characterize disease trends, frequencies, incidence/prevalence, co-morbidities, safety outcomes, risk factors and treatments.
Collaborate with Internal and External Customers
Communicate and collaborate effectively with relevant internal business partners, Development teams and Medical Affairs and Regulatory Scientists as part of issue management teams and in preparation of responses to requests posed by regulatory authorities; support them regarding safety information requests and other safety activities
Collaborate with external partners and participate in key external initiatives.
Leverage Analytic Tools
Leverage analytic tools to support activities such as disease state characterization, signal detection, clarification, and evaluation utilizing multiple data sources (e.g., spontaneous case reports, health claims and electronic health records)
Requirements
A PhD or DrPH in epidemiology or other related subject with high epidemiologic content; or Master in Epidemiology with at least 2 years in conducting epidemiological studies
Ability to conduct epidemiology research including preparation of study protocols and statistical analysis plans
Competent in the independent analysis of data from clinical and epidemiology studies, and interpretation of the study results
Excellent computer skills; knowledge of SAS, SPSS, and/or equivalent statistical software package.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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