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Post : Clinical Surveillance Scientist
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 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
• 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 CRS/CRP, 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
• Bachelors or Master’s degree in pharmacy/ healthcare-related/ life science with 2-3 years’ experience in signal detection and safety data evaluation, risk assessment, regulatory inquiries, and periodic reporting
• 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
Experience : 2-3 years
Qualification : Bachelors or Master’s degree in pharmacy / life science
Location : Bengaluru
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th November, 2021
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