Lilly Senior Research Scientist, Epi-Patient safety in Shang Hai-上海, China
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.
Senior Research Scientist, Pharmacoepidemiologist - Patient Safety
The purpose of the pharmacoepidemiologist role is to provide pharmacoempidemiology leadership and technical support to GPS China and other functional areas within the company.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Design, coordination, implementation of observational studies to support product development and the post-marketing environment
Collaborate with cross-functional teams to ensure high quality methodological content in study proposals, protocols, analysis plans, study reports, abstracts and publications, and other documents
Demonstrate knowledge of relevant Chinese and global regulatory requirements and practice, act as SME in development and implement of the safety quality system and training tools/programs when relating to epidemiology
Assessing the need for pharmacoepidemiology and database studies to support product development and the post-marketing environment
Support global PE studies as local expertise if necessary
Risk management/risk minimization activities where pharmacoepidemiologic expertise/data/approaches are required.
Standards and Inspection Readiness
Ensures relevant SOPs are well understood across the affiliate(s), leading and providing clarification on local implementation
Supports the development of global SOPs to ensure alignment with local laws and regulations
Quality Control and Planning
Helps to interpret relevant regulations and guidelines and acts as a contact person in the affiliate
Sets up and maintains the relevant quality system at affiliate level to meet regulatory expectation and business need
Minimum Qualification Requirements:
A PhD or MPH or Dr.PH in epidemiology.
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
Have strong analytic skills, oral and written communication skills both in Chinese and English, strong interpersonal and leadership skills
Be able to work independently
Other Information/Additional Preferences:
Knowledge of Pharmacovigilance regulation in China is preferred
Be willing to travel
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!