Sr. Clinical Research Scientist, GPS/Associate Medical Advisor, GPS
Shanghai, Shanghai Municipality
The purpose of the Patient Safety Physician / Patient Safety Associate Medical Advisor in Lilly China is to perform clinical/medical safety functions within China Affiliate. These include performing as Local
Therapeutic Safety Physician to support the management and evaluation of safety information by performing medical monitoring of individual case safety reports (ICSRs) and aggregated safety data in compliance with established procedures; demonstrating Global Patient Safety (GPS) expertise and leadership and acting as the local Safety representative for Lilly products or molecules for both internal and external customers with interaction in accordance with the corporate guidelines and policies; interfacing with the Global GPS physicians to reach resolution on local safety matters; Providing input into the changes in China regulatory environment specifically on the risk management requirements; providing safety-related training /coaching /mentoring to staffs. Additionally, individualized responsibilities for a particular product/project/expertise will be discussed and agreed at an individual level.
- Local Therapeutic Patient Safety Physician- Patient/Product Safety responsibilities
- Demonstrates knowledge in pharmacovigilance which includes an understanding of relevant aspects of applicable local laws, regulations and guidance, and Lilly’s GPS Standards, policies and procedures.
- Provides medical input and review of local adverse event (individual case safety reports or aggregated safety data) as appropriate.
- Builds collaborative working relationships and liaises with local/global functions [e.g. Global GPS Physician, local Business Unit Medical Physician, Exploratory Medicine (EPM), Development and Brand Teams] to fulfill safety obligations and high quality medical evaluation of safety data.
- Provides safety evaluation (e.g. safety analysis, expectedness assessment) and medical consultation on local compensation claim related to safety issue arisen from the use of Lilly products.
- Local Risk Management Responsibilities
- Demonstrates knowledge in risk management, which includes an understanding of relevant aspects of applicable laws, regulations and guidance on risk management /minimization.
- Provides input into the changes in China regulatory environment specifically on the risk management requirements.
- Provides consultation, preparation, and maintenance of the safety sections of the China Risk Management Plans, and take part in risk management activities for China Affiliate.
- Local Safety Surveillance Responsibilities
- Takes part in and provides guidance on local surveillance activities, including signal detection, safety clarification and risk evaluation activities, through interfacing with Global GPS Physician/Surveillance, as appropriate.
- Provides consultation on local safety surveillance to appropriate committees/Product Development and Brand Team.
- Product labeling Responsibilities
- Represents local GPS position to Global Products Labeling Committee, as appropriate.
- Assists in the preparation of the safety section of Draft Launch Label applicable to China.
- Reviews reports on safety issues and their implications for the Core Safety Information applicable to China.
- Local Clinical Trial / Post Marketing Surveillance Study Responsibilities
- Provides consultation, preparation, and maintenance of the safety sections of Clinical Trial/ Post-Marketing Study protocols, study reports and other relevant documents.
- Provides medical support for safety-related medical activities and reports, as appropriate.
- GPS Leadership for Lilly China
- Builds strong relationships with key customers, representing and championing the role of safety in Lilly China organization, and provides input to China Patient Safety Team and Safety Review Committee for decision making, influence, and problem solving related to China Patient Safety.
- Acts as the Lilly China GPS representative for both internal and external regulatory customers [e.g. Lilly China Regulatory Affairs, China Regulatory Authority - State of Food and Drug Administration (SFDA)] and provides input on China regulatory policies and trends affecting Global Patient Safety.
- Provides ad-hoc involvement in China Patient Safety operations, as required and performs other safety-related work considered business critical as necessary.
- Understanding and Support of the Qualified Person for Pharmacovigilance (QPPV)
- Understanding the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance
- Ensure support is provided to enable the local Qualified Person to fulfill all the Qualified Person legal responsibilities, in accordance with the local applicable regulations.
- Safety-related Training，Coaching, Mentoring
- Provides training (e.g. Safety Surveillance), coaching and mentorship to China safety team and other medical staff if necessary
- Maintains compliance with Lilly Red Book and Corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum maps.
- Develops GPS expertise through discussion and internal/external training program.
- Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections
Basic QualificationsMinimum Qualification Requirements:
- The Medical Doctor 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.
- Clinical research or pharmaceutical medicine experience preferred.
- Knowledge of drug development and clinical research process.
- Fluent in English and Mandarin; both written and verbal communications. Excellent 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.
- Facility in the use of computer-related tools essential (e.g. word processing, e-mail, web browsers).
- Ability to work in a global environment (virtual tools).
- Patient/Drug safety experience.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID 54631.
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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