Pharmacovigilance Specialist

Welcome to Eli Lilly and Company! We are a global pharmaceutical company dedicated to creating innovative medicines that help improve the lives of patients around the world. As a Pharmacovigilance Specialist at our company, you will play a crucial role in ensuring the safety and effectiveness of our products. We are seeking a highly skilled and detail-oriented individual with a strong background in pharmacovigilance to join our team. If you are passionate about making a difference in the healthcare industry and have the necessary qualifications, we would love to hear from you. Join us in our mission to make life better through our medicines.

1. Monitor and analyze safety data for all products in accordance with global regulatory requirements and company policies.
2. Conduct signal detection and risk management activities to identify potential safety concerns.
3. Collaborate with cross-functional teams to assess and communicate safety information to internal and external stakeholders.
4. Maintain and update pharmacovigilance databases and ensure accurate and timely reporting of adverse events.
5. Review and evaluate safety data from clinical trials, post-marketing surveillance, and other sources to support product development and post-marketing safety activities.
6. Contribute to the development and implementation of pharmacovigilance processes and procedures.
7. Participate in the preparation of safety reports, including Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
8. Keep abreast of relevant pharmacovigilance regulations and industry best practices to ensure compliance and continuous improvement.
9. Serve as a subject matter expert for pharmacovigilance and provide guidance and training to colleagues as needed.
10. Represent the company in interactions with regulatory authorities and external partners on safety-related matters.
11. Identify and escalate potential compliance issues to management and assist with corrective actions.
12. Contribute to the development and maintenance of pharmacovigilance systems, including SOPs, work instructions, and training materials.
13. Support the safety evaluation of new product applications, variations, and other regulatory submissions.
14. Participate in cross-functional initiatives and projects to drive continuous improvement and enhance the safety profile of our products.
15. Foster a culture of safety and compliance within the organization through effective communication and collaboration with all stakeholders.

According to JobzMall, the average salary range for a Pharmacovigilance Specialist in Austin, TX, USA is between $73,000 and $118,000 per year. Factors such as level of experience, education, and employer can influence this range. The median salary for this position is around $95,000 per year.

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.