Senior, Clinical Safety Analyst

Role: Senior Clinical Safety Analyst responsible for reviewing and analyzing safety data from clinical trials to ensure compliance with regulatory standards and contribute to product safety. Responsibilities include safety surveillance, adverse event coding and medical review, managing safety-related queries, and preparing safety reports. The analyst collaborates with cross-functional teams such as Clinical Research, Data Management, and Pharmacovigilance, providing safety oversight and support for study safety plans and regulatory submissions. Qualifications: Bachelor's degree in health sciences, with RN or clinical pharmacy experience strongly preferred; minimum 3 years of clinical experience with at least 1 year in drug safety or 2 years clinical plus 3 years safety experience. Technical skills include proficiency in databases like Oracle/Clinical and Microsoft Office. Critical evaluation and medical presentation skills are essential. Preferred candidates have experience in pharmacovigilance, regulatory compliance (ICH, FDA, EMA), and safety data analysis. Work involves primarily study-related safety activities with some higher-level safety functions, requiring good judgment and communication skills. The role may include mentoring junior staff. Location and travel details are not specified but are typically aligned with clinical safety operations.