<ul><li>Monitor, evaluate, and report adverse drug reactions (ADRs) and product complaints to regulatory authorities.</li><li>Review and process safety data from clinical trials, post-marketing surveillance, and medical literature.</li><li>Ensure compliance with pharmacovigilance regulations, including FDA, EMA, and ICH guidelines.</li><li>Perform signal detection, risk management, and periodic safety update reports (PSURs).</li><li>Collaborate with healthcare professionals and internal teams to gather and assess safety information.</li><li>Maintain accurate and up-to-date pharmacovigilance databases and safety documentation.</li><li>Prepare and submit adverse event reports to regulatory agencies in a timely manner.</li><li>Conduct risk assessments and provide recommendations for risk minimization strategies.</li><li>Participate in audits and inspections to ensure adherence to safety regulations and guidelines.</li><li>Support training and awareness initiatives for staff on pharmacovigilance practices and safety reporting.</li></ul>

Pharmacovigilance Executive