Clinical Surveillance Scientist

Location Type: Not Specified

Industry:

Company: Eli Lilly and Company

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$111,000 – $162,800

Purpose:

The Global Patient Safety (GPS) organization is responsible for delivering scientific, medical and pharmacovigilance expertise in support of Lilly’s products in development as well as for marketed medicines and devices globally. The Clinical Surveillance Scientist leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. In this role, you will apply effective prioritization, critical thinking, and judgment based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders is an important capability for this role.

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.

Signal Detection and Safety Data Evaluation

• Drive the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile and consult and collaborate with other safety personnel as appropriate.
• Develop and review label changes and labelling modifications in collaboration with teams, regulatory and legal.
• Apply effective communication skills to lead and facilitate safety team meetings for compounds in clinical development and marketed products
• Define data acquisition strategy, methodology, and approach for safety evaluations. Perform analysis of safety data and lead authoring of safety topic reports
• Collaborate with GPS Medical physicians, scientists, pharmacoepidemiologists, and other personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy
• Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner.
• Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions

Risk Assessment, Regulatory Inquiries, and Periodic Reporting

• Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs)
• Provide input to safety communications in the form of labeling, medical information inquiries, and healthcare professional (HCP) letters

Promote and Advance the Field of Pharmacovigilance

• Responsible for effective communication and influence with internal Lilly customers (e.g. medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies)
• Accelerate the advancement of and contribute to the development and coaching of peers and less experienced employees
• Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity
• Effectively function and communicate as part of inclusive cross functional teams (e.g. GPS Medical physicians and scientists, Pharmacoepidemiologists, Research and Business Unit team members, other safety personnel) that foster trust, respect, and accountability
• Demonstrate and apply pharmacovigilance knowledge, including the role of the QPPV, to ensure compliance with local laws and regulations
• Adhere to requirements in quality system documents and process improvement initiatives to ensure compliance with local laws and regulations

Minimum Qualification Requirements:

• Advanced medical related graduate degree, such as: pharmacy (PharmD), nursing with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner), PhD with 1-3 years 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.

Additional Preferences:

• Clinical knowledge of various disease states, drug effects, human physiology and pharmacology
• Experience within Global Patient Safety or demonstrated understanding of Pharmacovigilance is preferred
• Demonstrated ability to manage multiple deliverables simultaneously
• 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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