Opportunity to work as Clinical Surveillance Scientist at Lilly- Apply before 30th October 2024

Job Title: Clinical Surveillance Scientist

Location: Bangalore, Karnataka

About Lilly

At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our team works passionately to discover and deliver life-changing medicines. Our commitment to improving patient lives, enhancing disease management, and giving back through philanthropy drives everything we do. We put people first and strive to make a positive impact worldwide. If you are determined to make a difference, Lilly offers an exciting opportunity to join our team.

Job Purpose

The Clinical Surveillance Scientist will work within the Global Patient Safety (GPS) organization, contributing to the safety monitoring and pharmacovigilance of Lilly’s products. You will apply clinical and scientific expertise to identify safety signals, assess risks, respond to regulatory queries, and provide essential safety reports for products in development and on the market. This role requires critical thinking, prioritization, and effective communication with internal teams and regulatory agencies globally.

Key Responsibilities

• Lead the detection, analysis, and evaluation of safety signals from various data sources to assess risks and make recommendations for label changes or benefit-risk modifications.
• Collaborate with cross-functional teams to develop, review, and communicate safety-related labeling changes.
• Facilitate safety team meetings and lead discussions related to safety evaluations for both marketed products and those in clinical development.
• Define data acquisition strategies and perform safety data analysis to support safety reports and regulatory submissions.
• Work closely with GPS Medical physicians, scientists, pharmacoepidemiologists, and regulatory personnel to ensure comprehensive safety evaluations and compliance with global safety regulations.
• Author relevant safety sections for regulatory reports such as DSURs, PADERs/PAERs, PSURs, PBRERs, and Risk Management Plans (RMPs).
• Provide safety input for communications including medical information inquiries and healthcare professional (HCP) letters.
• Contribute to coaching and mentoring peers, while also identifying innovative approaches to enhance productivity and organizational effectiveness.
• Ensure compliance with local and global pharmacovigilance regulations and contribute to continuous quality improvement.

Candidate Profile

• Advanced Degree: Pharmacy (PharmD), Nursing (Clinical Nurse Specialist/Nurse Practitioner), PhD in a relevant scientific field (e.g., pharmacology, physiology), with 1-3 years of experience in a related field.
  OR
• BS Degree: In a health-related or scientific field with 7-10 years of pharmaceutical industry experience or related clinical trial expertise.
  OR
• Experience: 3-5 years of clinical experience or pharmaceutical experience, with at least 2 years in clinical development.
• Strong clinical knowledge in disease states, drug effects, human physiology, and pharmacology.
• Experience in pharmacovigilance or a demonstrated understanding of Global Patient Safety is preferred.
• Proven ability to manage multiple deliverables and prioritize effectively in a fast-paced environment.

Additional Information

• Industry Type: Pharma / Healthcare / Clinical Research
• Functional Area: Research & Development
• End Date to Apply: 30th October 2024

Lilly is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

If you’re passionate about improving patient outcomes and advancing global health, apply today to make life better at Lilly!

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