Job title: Intern – Clinical Surveillance Scientist
Job description: 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
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: Signal Detection and Safety Data Evaluation 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 safety physicians, medical directors, 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 Support 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 labelling, 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, labelling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies) Effectively function and communicate as part of inclusive cross functional teams (e.g. GPS Medical CRS/CRP, Pharmacoepidemiologists, Research and Business Unit team members, other safety personnel) that foster trust, respect, and accountability Demonstrate and apply pharmacovigilance knowledge 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) or Master’s degree in healthcare-related/ life science or Bachelor’s degree in pharmacy Additional Preferences: Clinical knowledge of various disease states, drug effects, human physiology and pharmacology 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
Location: Bangalore, Karnataka
Job date: Thu, 10 Feb 2022 23:40:16 GMT
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