Director/Sr Director/Executive Director – Global Patient Safety-Medical Product Safety Assessment Physician in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Director/Sr Director/Executive Director – Global Patient Safety-Medical Product Safety Assessment Physician in Indianapolis, Apply Lilly careers in Indianapolis Indiana.


Position : Director/Sr Director/Executive Director – Global Patient Safety-Medical Product Safety Assessment Physician

Location : Indianapolis, Indiana

Job id: R-33809


Job Details

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.The purpose of the Product Safety Assessment Senior Medical Advisor/Medical Advisor is to perform medical roles as a part of the Global Patient Safety (GPS) function in assessing the potential patient safety implications associated with the manufacturing, packaging, transportation and storage of Lilly products. Additional duties may include activities that are part of the job description for the Senior Medical Advisor/Medical Advisor in Global Patient Safety (GPS) Medical, as required.Primary Responsibilities:The job requirements of any position may change over time and may include additional responsibilities not specifically described in this job description.  1. Product Safety AssessmentsProvide the medical assessment component of corporate Product Safety Assessments (PSAs) and Health Hazard Evaluations (HHEs).Provide the medical assessment component of prospective health impact assessments for both the manufacturing and development environments.Provide evaluation of individual adverse events for possible manufacturing-related root cause for Lilly productsAssist in development and implementation of training to all Lilly manufacturing sites regarding the PSA/HHE process and monitor compliance with the PSA/HHE process at manufacturing sites.Responsible for appropriate implementation of PSA/HHE process with manufacturing and/or marketing partners.Develop and conduct safety training, as needed, at designated affiliates for global cGMP compliance activities in GPS,Member of the Quality-GPS (AE/PC) surveillance committee evaluating aggregate product complaint/adverse event data for potential common or manufacturing-related causes.Assist in development and implementation of training to all Lilly manufacturing sites regarding the AE/PC Surveillance, as neededPrepare medical complaints in response to signals identified during AE PC Surveillance. Review and approve/reject manufacturing investigation results in response to medical complaints.Assist with prospective adverse event monitoring of product lots associated with HHEs.2. Safety MonitoringProvide medical leadership to the multifunctional teams involved in collecting and analyzing data, linking product complaints and adverse events for all Lilly products.Responsibilities will include:Supervise medical review of adverse event (AE) reports for completeness, accuracy, relevance and, if needed, assess possible relatedness where issues regarding product quality need to be considered Assist in the development and maintenance of processes for monitoring potential safety signals that may be associated with product quality deviationsParticipate in medical/quality assessments at GPS Safety meetings, Quality Leadership forums and other management meetings.Review or write special topics in PSUR’s or other cumulative reviews of spontaneous or clinical trial data related to potential manufacturing safety issues and provide analyses and integrated summaries, as assigned.Assist in responses to regulatory safety inquiries involving medical assessments of potential manufacturing quality deviations, as neededParticipate in the development of surveillance programs/risk management plans for new products relating to potential risks associated with relevant product attributes.Participate in the development / delivery of appropriate training and accountability for all GPS Medical physicians/CRSs aimed at cGMP compliance and identification of potential manufacturing-related safety signals through adverse event evaluationAssist in surveillance programs for prospective monitoring of HHE-related released lots.Function as a consultant to drug development clinical teams on quality and medical safety issues specific to manufacturing quality issues, counterfeiting issues, specification issues, device issues or connected care issues.Serve as a medical consultant SME within GPS regarding manufacturing quality, as needed.Maintain knowledge of relevant GCP, GMP and pharmacovigilance regulations and evolving regulatory environmentsParticipate in device safety monitoring within GPS3. Leadership in GPS and QualityProvide leadership for internal policy development, strategy and other aspects of the operations relating to AE/quality processes.Provide leadership in interpretation of manufacturing and manufacturing quality related regulations and serve as a consultant to organizations within Lilly to ensure compliance with such regulationsFunction as a physician resource for product recall assessments4. Cross-functional Expertise ExpectationsLiaison with the clinical development teams. affiliates. and other Lilly departments in addressing manufacturing related, issues including development and design) generated by regulatory agencies and internal groups (for example labeling, regulatory, legal, media, medical and communications) and provide safety data and interpretation of the data to respond to inquiries about Lilly’s productsServe as a GPS representative or regular member for cross-functional committees within Lilly, as assigned, including (but not limited to) the Device Safety Lead Team, Medical Software Lead Team, 3 Day Field Alert triage, Drug Shortage triage team, Product Recall triage group, Product Complaint triage group, Biotechnology Corporate Safety Committee, Small Molecule Corporate Specification Committee, Comparability Assessment Committee, Bioproduct Bridging Working Group, and Product Protection – Product Risk Assessment team (Anti-Counterfeiting), as requiredServe as GPS and Quality Designated Physician Liaison with device manufacturing and development teamsServes as a consultant to Brand or Product Teams for evaluation of device or manufacturing related information in promotional and marketing materials, as needed.Provide clinical support to GPS organization members responsible for processes related to the capture and analysis of data, linking product complaints and adverse events.Assist in development and implementation of processes to identify counterfeit, “similar°’ and/or contaminated products that are associated with adverse events.5. Methods development to support product safety assessment processesCollaborate with the epidemiologists within GPS for potential safety signal monitoring, especially focused on potential manufacturing-related root causesProvide leadership to conduct Pharmacoepidemiology studies and research for important issues and relevant signal monitoring, specific to manufacturing deviations, manufacturing changes, product complaint concerns, changes in specifications or device development, where applicable6. Interaction with Product or Molecule Safety PhysicianProvide medical input into specified aspects of safely for assigned product(s) including surveillance programs and risk management planning, as requiredCommunicate with GPS Medical Area Directors and with Lilly Medical Therapeutic Area Team Leaders and Directors, as appropriate, to fulfill safely obligationsBuild collaborative working relationships with other Global Patient Safety Physicians and development / brand team’s medical personnel to ensure full cooperation and high quality medical evaluation of safety data for global regulatory purposes.7. Understanding and Support of the QPPV roleUnderstand the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance (EU QPPV) and ensure their involvement in the pharmacovigilance system and processesEnsure support and information are provided to enable the QPPV to fulfill all the OPPV legal responsibilities.Minimum Qualification Requirements:Medical Doctor or Doctor of Osteopathy. Must be board-eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.US trained physicians must have achieved board eligibility or certification.Foreign medical graduates (in US based jobs) who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).  For the recognized list of foreign medical schools and the disapproved list, see Information/Additional Preferences:Post-medical school clinical training in occupational and environmental medicine or pharmacology preferredClinical research or pharmaceutical medicine experience preferredKnowledge of the drug development processClinical experience preferred.Fluent in English; both written and verbal communicationsExcellent interpersonal, organizational and negotiation skillsAbility to influence others (both cross-functionally and within the function) in order to create a positive working environment.Excellent teamwork skills.Willing to engage in domestic and international travel to the degree appropriate to support the business of the teamBasic knowledge of GMP and GCP regulationsStrong clinical/diagnostic skillsStrategic thinkingWork experience in areas relevant to drug discovery, development. or manufacturing, (e.g. epidemiology, statistics, toxicology, pharmacovigilance, regulatory affairs, pharmacology, occupational and environmental medicine)Demonstrated success in implementing projectsGood communication skills, both verbal and writtenFacility in the use of computer-related tools essential (e.g. word processing, email, web browsers)Ability to work in a global environment (virtual tools and travel)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 ( ) 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 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).



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