Pharmacovigilance Specialist Full-time Job

The Pharmacovigilance Specialist is responsible for the monitoring and analysis of adverse drug reactions (ADRs) from various sources including clinical trials, post-marketing data, and spontaneous reports. This role involves reviewing and processing individual case safety reports (ICSRs) to ensure that all adverse events are accurately captured and reported in accordance with regulatory requirements. The specialist collaborates with clinical research teams, regulatory affairs, and other departments to ensure comprehensive safety evaluations and risk assessments. The role also includes conducting signal detection activities and analyzing trends in safety data to identify potential risks associated with drug products. Responsibilities extend to preparing and submitting periodic safety update reports (PSURs) and other regulatory submissions, as well as participating in safety meetings and audits. The specialist must maintain up-to-date knowledge of global pharmacovigilance regulations and guidelines, and ensure compliance with local and international standards. Strong analytical skills, attention to detail, and the ability to work independently are crucial for this position. Experience with pharmacovigilance databases and safety signal detection tools is required. The role may involve occasional travel to attend conferences or regulatory meetings. In addition to technical skills, effective communication and teamwork are essential, as the specialist will interact with various stakeholders, including healthcare professionals, regulatory authorities, and internal teams. The role requires a degree in life sciences or a related field, with relevant pharmacovigilance experience preferred.