Senior Drug Safety Associate

Senior Pharmacovigilance Associate - Sofia, Bulgaria - hybrid ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. We are currently seeking a Senior Drug Safety Associate to join our diverse and dynamic team. As a Senior Drug Safety Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety. What You Will Be Doing: * 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. Your Profile: * 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. #LI-MK1 Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: * 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 Benefits may vary depending on role and location. Visit our careers site [https://careers.iconplc.com/benefits] to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here [https://careers.iconplc.com/reasonable-accommodations]. Are you a current ICON Employee? Please click here [https://wd3.myworkday.com/icon/d/task/1422$1235.htmld] to apply