- Effectively function as part of multifunctional teams (e.g., safety managers, surveillance scientists, project managers, physicians from clinical teams or affiliates, statisticians, epidemiologists, writers, data management)
- Effectively interface with the global GPS organization, including safety groups in Affiliates and Regional Centers
- Core responsibilities will include, but are not limited to: Review adverse event reports and medical literature cases for completeness, accuracy, relevance and, if needed, assess relatedness. Initiate appropriate follow-up and update essential medical information on all reports. Provide Consultation as a team member to early (pre-commercialization decision) drug development clinical teams. Assist in the preparation of safety section of Draft Launch Label. Provides consultation, preparation, and maintenance of the safety sections of the Safety Section of the Clinical Plan, Clinical Investigator Brochure, Developmental Core Safety Information, Risk Profile, Risk Management Plans, Summary of Clinical Safety and Core Data Sheet. Take part in and guide the surveillance activities including signal detection, clarification and risk evaluation activities; provide support, training and continued improvement as appropriate. Manage decisions and actions to be taken, including communication to appropriate customers (Business Unit leaders, Product team, Management, Affiliates, Regulators). Liaise with GPS Medical physicians and leadership, as appropriate, to fulfill safety obligations. Liaise with GPS Medical Leaders and Development and Brand Teams, as appropriate, to fulfill safety obligations. Review reports on safety issues and their implications for the Core Safety Information. Monitor potential safety signals through safety surveillance team, safety management team and periodic safety review meetings. Review or write special topics in PSURs or other aggregate reviews of spontaneous or clinical trial data submitted to regulatory agencies and provide analyses and summaries for these reports. Provide Global Patient Safety expertise to internal and external customers (e.g., regulatory, Affiliates, FDA, COE, Discovery and Clinical Research, Business Units). Demonstrate knowledge in pharmacovigilance and risk minimization, which includes and understanding of relevant aspects of applicable laws, regulations and guidance. Develop Global Patient Safety expertise through discussion and training programs. Understanding and Support of the QPPV role
- Understanding the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance (QPPV).
- Ensure support is provided to enable the QPPV to fulfill all the QPPV legal responsibilities Training, Coaching, Mentoring
- Provide training, coaching and mentorship to safety surveillance scientists, and other Global Patient Safety Medical physicians and clinical research scientists.
- Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum map.
- Maintain compliance with the Lilly Corporate Integrity Agreement. Global Patient Safety Medical Leadership
- Provide input to Global Patient Safety Medical Leadership Team and Safety Review Committee as required.
- Provide ad-hoc involvement in operations, if required.
- Act as the Lilly GPS Medical 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: Product Team Leaders and Business Unit Leadership. Regulatory. Affiliate leadership and physicians. COE and Discovery and Clinical Research. External opinion leaders in Global Patient Safety. Represent Global Patient Safety within the company and externally; and review and comment on external regulatory policy and trends affecting Global Patient Safety. A CRS, GPS Medical is expected to meet the criteria as outlined in the global path job criteria for appropriate R path level positions.
- For each level on every global path, there are a consistent set of job criteria which includes functional and technical expertise, decision making, influence, and problem solving.
- Perform other work considered business critical as necessary. 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' experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field. OR
- BS degree in 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 2-5 years of pharmaceutical experience, at least 2 years of which was clinical development experience. Other Information/Additional Preferences:
- Fluent in English; both written and verbal communications.
- Strong clinical/diagnostic skills.
- Strategic thinking.
- Demonstrated success in implementing projects.
- Good communication skills, both verbal and written.
- Team player.
- Ability to effectively function in a matrix environment.
- Interpersonal, organizational and negotiation skills.
- Ability 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 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 ( ) 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. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly -
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Clinical Research Scientist, GPS Medical - Indianapolis, United States - Eli Lilly and Company
Description
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 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.
Purpose:
The purpose of the Clinical Research Scientist, GPS Medical is to perform clinical safety functions within Global Patient Safety Medical, including supporting product/project teams using safety expertise. The CRS will support the management and evaluation of safety information by performing medical monitoring of individual case reports (ICRs) and aggregate data in compliance with established procedures.
The CRS will perform as the Therapeutic Product Patient Safety Scientist demonstrating Global Patient Safety expertise and is Lilly GPS Medical product or molecule representative for both internal and external customers interacting as prescribed in corporate guideline and policies.
Individualized responsibilities for a particular product/project/expertise will be discussed and agreed at an individual level.
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.
Safety Monitoring
