# Senior Pharmacovigilance Associate **Company**: ICON **Location**: Sofia **Work arrangement**: hybrid **Experience**: senior **Category**: Healthcare **Industry**: Healthcare **Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Bulgaria-Sofia/Senior-Pharmacovigilance-Associate_JR147140?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_28de14ca-cc4 ## Description ICON is seeking a Senior Pharmacovigilance Associate to join their team in Sofia, Bulgaria. As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities. **Responsibilities:** - Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies. - Set-up, maintain and close-out studies as a PV Lead; writing Safety Management Plans, performing PV budget reviews and attending client meetings. - Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices. - Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements. - Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization. **Requirements:** - Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. An advanced degree is preferred. - Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards. - Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection. - Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations. - Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams. - Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite. - Ability to work independently and manage multiple priorities in a fast-paced environment. - Commitment to maintaining confidentiality and handling sensitive patient information with discretion. **Rewards & Benefits:** - Competitive base salary and performance related incentives - Health and wellbeing programmes including medical, dental, and vision coverage where applicable - Retirement and pension plans - Life assurance and disability coverage - Employee assistance programmes and wellbeing resources - Learning and development opportunities through structured training and career pathways ## Skills ### Required - pharmacovigilance - drug safety - regulatory guidelines - Microsoft Office Suite --- Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Bulgaria-Sofia/Senior-Pharmacovigilance-Associate_JR147140?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)