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.
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.
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 document 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. OR
- 3-5 years of clinical experience or 3-5 years of pharmaceutical experience, at least 2 years of which was clinical development experience
Other Information/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.
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