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based on 389 Reviews

55 Eli Lilly and Company Jobs

Clinical Surveillance Scientist

Eli Lilly and Company

based on 389 Reviews

1-10 years

Bangalore / Bengaluru

1 vacancy

Clinical Surveillance Scientist

Eli Lilly and Company

posted 2mon ago

Flexible timing

Key skills for the job

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Eli Lilly and Company is looking for Clinical Surveillance Scientist to join our dynamic team and embark on a rewarding career journey

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.

Employment Type: Full Time, Permanent

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