Senior Pharmacovigilance Officer Full-time Job

The Senior Pharmacovigilance Officer leads a team of pharmacovigilance professionals and is responsible for overseeing the monitoring, evaluation, and reporting of drug safety data. This role involves managing the pharmacovigilance activities to ensure compliance with global regulatory requirements and company policies. The officer reviews and approves individual case safety reports (ICSRs), periodic safety update reports (PSURs), and other safety-related submissions. They are also responsible for conducting safety signal detection and risk assessments, and developing risk management strategies to mitigate identified risks. The role requires a strong understanding of pharmacovigilance regulations, as well as experience in managing safety data and preparing regulatory submissions. The officer collaborates with clinical teams, regulatory affairs, and other departments to ensure that safety data is effectively communicated and addressed. They also participate in audits and inspections, and lead efforts to address any findings or compliance issues. Strong leadership skills are necessary to manage and mentor a team, and effective communication skills are required for interacting with regulatory authorities and internal stakeholders. The position demands a high level of expertise in pharmacovigilance, as well as the ability to work independently and make strategic decisions. A degree in life sciences or a related field is required, along with significant experience in pharmacovigilance and regulatory affairs. The role may involve occasional travel for meetings and training.