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Clinical Surveillance Scientist

3 weeks ago

Bengaluru Karnataka, India Lilly Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Purpose**:
**Primary Responsibilities**:
**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.
- 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.

**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
- 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.

Lilly 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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