Sr. Associate Manager - GPS and PHV
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 Global Patient Safety (GPS) - Global Medical Review Clinical Research Scientist and Senior Clinical Research Scientist role is to be a full-time member of the Global Patient Safety (GPS) organization. Primary responsibilities for this position include accountability for local safety related activities, collaboration with the GPS Medical physicians and scientists regarding safety surveillance issues and, if applicable, provide leadership for Global Patient Safety (GPS) Safety Management, Reporting and Safety Data Sciences (SMRD).
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 supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
Medical support of individual case adverse event reporting process
- Provide the medical and clinical expertise necessary to support case managers and call center staff involved in receiving, preparing, and reporting adverse events.
- Provide medical technical expertise in evaluation of adverse events, supporting the case management staff in ensuring appropriate follow-up, reviewing assessments, providing review for the medical content of Individual Case Safety Reports (ICSRs) as needed, and making the determination of the company’s assessment of relatedness for applicable ICSRs.
- To successfully meet these requirements, the Global Medical Reviewer will work closely with the GPS Medical physicians and scientists to ensure appropriate communication of safety issues (both locally and globally) and the medical quality of ICSRs.
- Identify or help support evaluation of potential quality issues with Lilly products that may adversely affect patient safety.
- Assist in supporting customer response activities associated with adverse events.
GPS Medical Leadership
As a medical representative of GPS for spontaneously reported and clinical trial individual case safety reporting, contribute to the global assessment of safety of Lilly products and molecules in clinical trials by interacting directly with the GPS Medical physicians and scientists and Safety Surveillance Teams (SSTs) involved in assessing the safety profile of Lilly products. This responsibility may require regular participation (in person or by teleconference) in relevant GPS global scientific and surveillance meetings related to management of marketed product and developmental product safety.
- Assist SSTs in review of specific individual ICSRs, bringing clusters of ICSRs from clinical trials suggesting a safety signal to the attention of SSTs, understanding case management specific issues and regulatory constraints, and conveying to the remainder of the Global Medical Review Group compound or trial specific issues and concerns.
- Build collaborative working relationships with other physicians and scientists in GPS Medical as well as Development and Brand Teams globally to ensure full cooperation and high-quality medical evaluation of safety data for Global Regulatory purposes.
Participate in process development, quality review, continuous inspection and audit preparedness and inspection/ audit support, and similar activities in response to a changing regulatory environment or corporate priorities.
Act as the Lilly GPS Medical Review representative for both internal and external customers, interacting as prescribed in corporate guidelines and policies.
Build strong relationships with key customers, representing and championing the role of safety in the organization.
As appropriate, provide leadership for Safety Management, Reporting and Safety Data Sciences (SMRD). This leadership might be provided through technical and/or administrative oversight of global case management activities.
- Provide technical excellence.
- Identify functional resources and build knowledge of pharmaceutical industry, include relevant aspects of the regulatory, industry, and scientific environments, laws, regulations, and guidance.
- Identify and communicate areas for scientific and process improvements and participate in change within the organization.
- Create an environment wherein training and mentoring is valued; facilitate the training of other Medical Reviewers in the responsibilities of the role, as needed.
Understanding and support of the QPPV role
- Understand the roles and responsibility of the European Union Qualified Person for Pharmacovigilance (QPPV).
- Ensure support is provided to enable the QPPV to fulfil the QP legal responsibilities.
Other Job expectations
- A GPS Medical Global Medical Review Clinical Research Scientist/Senior Clinical Research Scientist is expected to:
Meet the R&D Titles Expectations as outlined in the R&D Titles Framework. Maintain medical expertise in areas of interest or specialty Understand and comply with all compliance policies, laws, regulations, the Red Book and adapt to the changing global regulatory environment. Understand and comply with all compliance policies, laws, regulations, the Red Book and adapt to the changing global regulatory environment. Understand the confidential nature of company information and take necessary steps to ensure its protection. Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties.
Minimum Qualification Requirements:
- Advanced medical related graduate degree, such as: DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years of experience in related scientific field, e.g., pharmacology, physiology, microbiology or scientifically related field. OR
- BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g., epidemiology, toxicology, Pharmacovigilance, regulatory affairs. OR
- 3-5 years of clinical experience, or 3-5 years of pharmaceutical experience, at least 2 years of which was clinical development experience.
- Strong written, spoken, and presentation communication skills.
- Previous extensive clinical experience is essential.
- English language skills - fluent written and verbal communications.
- Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Other Information/Additional Preferences:
- Ability to work in a global environment (virtual tools and travel).
- Excellent teamwork skills.
- Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-25191.
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.
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