Loxo@Lilly Manager, Drug Safety Operations in Helena, Montana
Loxo@Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo@Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Louisville, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.
The Manager, Drug Safety will be responsible for providing Drug Safety/Pharmacovigilance support for new and ongoing clinical trials including the collection, processing, and reporting of adverse events/endpoints while adhering to International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, data protection guidelines and study procedures.
Roles and Responsibilities for the Position:
Perform triage of incoming Serious Adverse Event (SAE) reports and consider assessments of seriousness, listedness, and causality, coordinate triage review with medical monitor
Review case narratives, including identifying relevant information from source documents and write/review queries when additional information needed
Review data entry of SAEs in safety database including MedDRA coding
Coordinate medical monitor case review
Assist with the management of case processing deadlines
Assist in reconciliation between the safety and clinical databases for serious adverse events
Compile safety information for aggregate safety reports and other safety related reports.
Assist with ongoing safety surveillance
Assist with compilation and updating of safety related spreadsheets including metrics and SUSAR submissions
Review and update existing standard operating procedures (SOPs) and assist with creation of new SOPs for safety department as indicated
Provide oversight of work performed by a safety Contract Research Organization (CRO)
Contributor of safety input in study documents including DSUR, ICF, study protocols
Required Qualifications and Preferred Background:
RN, BSN or pharmacy degree with at least 3-5 years of industry experience in Clinical Trial Safety; industry experience from CRO or pharmaceutical/biotech setting will be considered
Previous experience in Health care is strongly preferred
Hands on experience with SAE case processing including narrative and analysis of similar event (AOSE) writing, and safety report generation
Working knowledge of MedDRA and WHODrug and FDA safety regulations, ICH guidelines, and global safety regulations
Hands on experience with global safety database(s); experience with Argus strongly preferred
Demonstrated ability to work well with other accomplished professionals within and across functions/teams
Willing collaborator with strong written and oral communication skills
Ability to multi-task and shift priorities rapidly to meet tight deadlines
Detail oriented and well organized
Self-motivated and keen to improve processes and overcome inefficiencies
Proficient in Microsoft Office suite and applications
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager position level could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.
Available Locations for this Role
Remote (US Based only)
South San Francisco, CA
The physical demands of this job are consistent with light office duties.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
Loxo Oncology, Inc. (“Loxo”) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email firstname.lastname@example.org for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response.