01Overview
Role Description The Pharmacovigilance Executive/Sr. Executive is a full-time, on-site role based in Bengaluru. This role is responsible for monitoring, collecting, assessing, and documenting adverse events and safety information related to the companys pharmaceutical products, in accordance with global regulatory requirements and internal standard operating procedures. The position involves evaluating case safety reports, preparing and reviewing periodic safety update reports, and supporting risk management activities to ensure patient safety and product compliance. The Pharmacovigilance Executive/Sr. Executive collaborates closely with regulatory affairs, quality assurance, medical affairs, and global partners to maintain accurate safety data and support inspections and audits. Day-to-day activities also include maintaining pharmacovigilance databases, contributing to safety signal detection, assisting in the development of safety-related documentation, and supporting internal training and continuous improvement initiatives.
Qualifications
Support the implementation, maintenance, and continuous improvement of the global pharmacovigilance (PV) system.Prepare, review, and maintain PV SOPs, work instructions, PSMFs, RMPs, and other safety-related documents.Manage adverse events, including review, assessment, processing, data entry, follow-up, and quality control of Individual Case Safety Reports (ICSRs).Perform MedDRA coding and ensure timely submission of safety reports to Health Authorities (HAs), as applicable.Support adverse event reporting activities and maintain accurate and compliant safety documentation.Perform scientific literature screening and review safety information from published literature and other relevant sources.Coordinate pharmacovigilance activities with internal stakeholders, affiliates, license partners, distributors, service providers, and other external stakeholders.Maintain high standards of data quality, accuracy, completeness, timeliness, and regulatory compliance across PV activities.Coordinate collection and reconciliation of aggregate safety data from affiliates, license partners, clinical/non-clinical sources, and other relevant databases.Support the preparation, review, and submission of aggregate safety reports, including PBRERs/PSURs, PADERs, and other periodic safety reports, as applicable.Identify, evaluate, document, and follow up on potential safety signals and support signal management activities.Support PV audits, inspections, CAPA implementation, and continuous improvement of the global PV quality system.Monitor changes in global PV regulations and guidelines and assess their impact on the company's PV system and processes. .
