Optum is a global organisation that delivers care, aided by technology to help millions of people live healthier lives.
The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best.
Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities.
Come make an impact on the communities we serve as you help us advance health equity on a global scale.
Join us to start Caring.
Connecting.
Growing together.
About the Role:At UnitedHealth Group and Optum, we want to make healthcare work better for everyone.
This depends on hiring the best and brightest.
With a thriving ecosystem of investment and innovation, our business in Ireland is constantly growing to support the healthcare needs of the future.
Our teams are at the forefront of building and adapting the latest technologies to propel healthcare forward in a way that better serves everyone.
With our hands at work across all aspects of health, we use the most advanced development tools, AI, data science and innovative approaches to make the healthcare system work better for everyone.
Nuvaila is seeking a dedicated and experienced Drug Safety Associate to join our growing team.
In this pivotal role, you will be responsible for ensuring the safety and efficacy of our products through meticulous pharmacovigilance activities.
We are looking for a highly motivated individual with a strong background in drug safety operations and a passion for patient safety.
If you are seeking a challenging and rewarding career in the pharmaceutical industry, we encourage you to apply for this exciting opportunity.Careers with Optum offer flexible work arrangements and individuals who live and work in the Republic of Ireland will have the opportunity to split their monthly work hours between our Dublin or Letterkenny and telecommuting from a home-based office in a hybrid work model.
Primary Responsibilities:• Document, reconcile and conduct reporting of adverse events per internal policies• Create and maintain internal procedures for documenting, reconciling and reporting of adverse events• Conduct necessary follow-ups and evaluations of adverse events, including reviewing medical records and collaborating with cross-functional teams• Maintain a thorough understanding of product safety profiles and provide timely updates to internal stakeholders• Monitor and analyze safety data to identify potential safety issues or trends and recommend appropriate actions• Develop and maintain strong relationships with external partners, such as other manufacturers and regulatory agencies• Support pharmacovigilance audits and investigations• Assist with the development and implementation of pharmacovigilance processes and procedures• Ensure compliance with all applicable regulations and guidelines related to pharmacovigilance• Support the preparation for pharmacovigilance inspections• Actively participate in pharmacovigilance inspections• Participate in cross-functional meetings and contribute to the development of risk management plans for products• Contribute to the continuous improvement of pharmacovigilance processes and systems• Stay updated on industry trends and changes in regulations related to pharmacovigilance• Maintain accurate and up-to-date documentation of all pharmacovigilance activities• Other duties as assignedYou will be rewarded and recognised for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role, as well as providing development for other roles you may be interested in.Required Qualifications:• Bachelor's degree in life science or healthcare (e.g., nursing, pharmacy)• Proven experience in a pharmaceutical/biopharmaceutical company• Competency in clearly and concisely articulating adverse events information to manufacturing partner• Ability to learn and successfully utilize Quality System software for adverse events reporting• Excellent communication and interpersonal skills• Analytical skills and attention to detail• Fluency in spoken and written English• Proficiency in Microsoft Word, Excel, PowerPoint, SharePoint, and Adobe Acrobat• Strong problem-solving skills• Capability to handle a high volume of work while maintaining high-quality standards• Ability to adapt to changing circumstances and effectively prioritize workload according to business needs• Demonstrated ability to manage projects simultaneously, ensuring compliance with regulatory requirementsPreferred Qualifications:• Experience with supporting FDA pharmacovigilance inspections and audits• Workflow management experience• Medical call center or medical claims experience is highly desirable• Demonstrated ability to use time efficiently, transcribe text or audio information accurately• Strong understanding of US and international PV regulations and best practicesPlease note you must currently be eligible to work and remain indefinitely without any restrictions in the country to which you are making an application.
Proof will be required to support your application.All telecommuters will be required to adhere to the UnitedHealth Group's Telecommuter Policy.At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone.
We believe everyone–of every race, gender, sexuality, age, location and income–deserves the opportunity to live their healthiest life.
Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalised groups and those with lower incomes.
We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission.Diversity creates a healthier atmosphere: Optum is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, civil status, family status, sexual orientation, disability, religion, age, race, and membership of the Traveller community, or any other characteristic protected by law.
Optum is a drug-free workplace.
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