Executive Director, Drug Safety Physician at Eli Lilly and Company
South San Francisco, CA
About the Job
Eli Lilly and Company seeks an Executive Director, Drug Safety Physician to ensure standard processes and procedures for all aspects of pharmacovigilance. Collaborate with safety systems associates, ensuring Argus support of safety reporting, audits and inspections, aggregate reports, and signal detection. Oversee SOPs development and management plans/procedures needed for the Clinical Safety Group. Effectively manage departmental resources, expenses, and budget. Provide expert pharmacovigilance guidance and leadership both internally and externally. #LI-DNI
Position requires an MD and 4 years of clinical experience in oncology. Experience must include a minimum of: 4 years of experience with regulatory requirements and guidelines pertaining to Drug Safety and Pharmacovigilance; 4 years of experience with safety concepts and Good Pharmacovigilance Practice; 4 years of experience with US and international regulatory reporting requirements for product safety; 4 years of experience with clinical development (including first in human studies), use of MedDRA, relational database applications including Argus, and safety database operations and functions; 4 years of experience supporting responses to US and international regulatory information requests as well as support of responses to Institutional Ethics Review Boards for creation and revision of informed consent documentation; and 4 years of experience working on multiple simultaneous projects while successfully prioritizing tasks. Part time telecommuting may be permitted. Up to 10% domestic travel required. #LI-DNI
Job location: South San Francisco, CA. Rate of Pay: $239,200.00 - $286,104.00 per year. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-66991 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Beth L. Berry, Lilly Corporate Center, Indianapolis, IN 46285.
Position requires an MD and 4 years of clinical experience in oncology. Experience must include a minimum of: 4 years of experience with regulatory requirements and guidelines pertaining to Drug Safety and Pharmacovigilance; 4 years of experience with safety concepts and Good Pharmacovigilance Practice; 4 years of experience with US and international regulatory reporting requirements for product safety; 4 years of experience with clinical development (including first in human studies), use of MedDRA, relational database applications including Argus, and safety database operations and functions; 4 years of experience supporting responses to US and international regulatory information requests as well as support of responses to Institutional Ethics Review Boards for creation and revision of informed consent documentation; and 4 years of experience working on multiple simultaneous projects while successfully prioritizing tasks. Part time telecommuting may be permitted. Up to 10% domestic travel required. #LI-DNI
Job location: South San Francisco, CA. Rate of Pay: $239,200.00 - $286,104.00 per year. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-66991 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Beth L. Berry, Lilly Corporate Center, Indianapolis, IN 46285.