Drug Safety Specialist

Pharmacovigilance Associate (Remote, Bulgaria) Join a Global Leader in Clinical Safety & Patient Protection We are seeking a Pharmacovigilance Associate to join a growing Clinical Safety team supporting international clinical research and medical device studies. This is an excellent opportunity for a detail-oriented professional who is passionate about patient safety, pharmacovigilance, and regulatory compliance, while working in a fully remote based in Bulgaria. As a Pharmacovigilance Associate, you will play a key role in supporting safety surveillance activities across clinical studies, ensuring high-quality safety documentation, data reconciliation, reporting, and compliance with global regulations and internal procedures. The role is ideal for candidates looking to build or further develop their career within Clinical Safety, Pharmacovigilance, or Drug Safety Operations. Key Responsibilities Support the preparation and maintenance of clinical safety reports and listings for ongoing studies. Gather, review, and compile safety information required for regulatory and complaint reporting activities. Perform safety data reconciliation and support data cleaning activities aligned with study milestones. Generate safety metrics and reports from multiple data sources. Maintain safety documentation in accordance with Good Documentation Practice (GDP). Ensure accurate filing of safety-related records within the Trial Master File (TMF). Assist with audit readiness activities and support inspections by maintaining complete and accurate documentation. Support Clinical Event Committee (CEC) meeting preparation and follow-up activities when required. Provide administrative and operational support for safety processes, systems, and workflows. Contribute to the continuous improvement of pharmacovigilance and clinical safety processes. Requirements Degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or a related field. Previous experience in Pharmacovigilance, Drug Safety, Clinical Safety, Clinical Research, or a related healthcare environment. Understanding of GCP, GDP, pharmacovigilance principles, and regulatory requirements. Experience working with safety databases, clinical trial documentation, or TMF systems is advantageous. Strong attention to detail and excellent organizational skills. Ability to manage multiple priorities and meet deadlines in a fast-paced environment. Proficient in Microsoft Office applications, particularly Excel. Strong written and verbal communication skills in English. What We Offer Fully remote role based in Bulgaria. Opportunity to work on global clinical studies and patient safety initiatives. Collaborative and supportive international team environment. Ongoing training and professional development. Exposure to cutting-edge clinical research and safety operations. Competitive compensation and benefits package. About Planet Pharma: Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. www.planet-pharma.com