
Drug Safety Associate
Are you passionate about making a positive impact on patients' lives? At Eli Lilly and Company, we are dedicated to discovering and developing innovative medicines to improve the health and well-being of people around the world. As a Drug Safety Associate, you will play an integral role in ensuring the safety and efficacy of our products. Your attention to detail and strong analytical skills will be critical in identifying, evaluating, and communicating potential risks associated with our medications. Join our team and be a part of our mission to make life better for people everywhere. To excel in this role, you must have a Bachelor's degree in a relevant field and a minimum of 2 years of experience in pharmacovigilance or a related area. You should also possess excellent communication and organizational skills, as well as the ability to work effectively in a fast-paced and dynamic environment. If you are ready to contribute to the advancement of healthcare and make a difference in the lives of others, we invite you to apply for this exciting opportunity at Eli Lilly and Company.
- Monitor and evaluate adverse event reports from healthcare professionals, patients, and clinical studies to ensure the safety and efficacy of our products.
- Collaborate with cross-functional teams to review and analyze safety data, and provide recommendations for risk mitigation strategies.
- Review and assess case reports for completeness and accuracy, and ensure timely and accurate submission to regulatory authorities.
- Develop and maintain knowledge of relevant regulations, guidelines, and company policies related to pharmacovigilance.
- Communicate safety information to internal and external stakeholders, including healthcare professionals, regulatory agencies, and patients.
- Participate in the development and maintenance of standard operating procedures and processes related to drug safety.
- Conduct ongoing monitoring and analysis of safety data to identify potential safety signals and trends.
- Work closely with other departments to support the development of new products and provide safety expertise.
- Support the preparation and submission of periodic safety reports to regulatory agencies.
- Provide training and support to colleagues on drug safety processes and procedures.
- Participate in cross-functional meetings and discussions to ensure the safety of our products.
- Contribute to continuous improvement initiatives to enhance drug safety processes and systems.
- Maintain accurate and up-to-date records of drug safety activities and documentation.
- Adhere to all relevant regulations, standards, and ethical principles in carrying out drug safety responsibilities.
- Continuously develop and enhance knowledge and skills in the field of pharmacovigilance.
Bachelor's Degree In A Relevant Field Such As Pharmacy, Life Sciences, Or Nursing
Minimum Of 2 Years Experience In Drug Safety Or Pharmacovigilance, Preferably In A Pharmaceutical Or Biotech Company
Strong Understanding Of Fda Regulations And Guidelines Related To Drug Safety Reporting And Adverse Event Management
Excellent Communication And Problem-Solving Skills, With The Ability To Work Effectively In A Team Environment
Familiarity With Pharmacovigilance Databases And Other Relevant Software, Such As Argus Or Arisg.
Risk Management
Data Analysis
Medical Terminology
Regulatory compliance
Clinical Trials
Drug Safety
Pharmacovigilance
Safety Reporting
Signal Detection
Adverse Events
Case Processing
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Drug Safety Associate in Dallas, TX, USA is between $53,000 and $82,000 per year. Salaries may vary depending on the specific company, experience level, and qualifications of the individual.
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Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Col. Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War.

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