Drug Safety Specialist in Biocon - Bangalore

Collect, review, and evaluate adverse event reports and other safety-related data to identify and assess potential risks associated with pharmaceutical products.Enter and maintain accurate and complete safety data in pharmacovigilance databases, ensuring data integrity and adherence to regulatory requirements.Prepare and submit expedited and periodic safety reports to regulatory authorities and other stakeholders in compliance with global pharmacovigilance regulations and guidelines.Collaborate with cross-functional teams to develop and update safety-related documents, including risk management plans, safety profiles, and product labeling.Conduct literature searches and review scientific literature for relevant safety information and signal detection.Participate in safety surveillance activities, including signal detection, evaluation, and management, to ensure timely identification and assessment of potential safety concerns.Assist in the development and implementation of pharmacovigilance processes, standard operating procedures (SOPs), and quality control measures.Support the preparation and execution of internal and external audits or inspections related to drug safety.Stay updated on evolving drug safety regulations, guidelines, and industry best practices.Contribute to the continuous improvement of drug safety processes, systems, and workflows.

Bachelor's degree in Pharmacy, Life Sciences, or a related field. An advanced degree or certification in Pharmacovigilance or Drug Safety is a plus.Minimum of [X] years of experience in pharmacovigilance, drug safety, or a related field, preferably in the pharmaceutical industry or a contract research organization (CRO).Knowledge of global pharmacovigilance regulations, guidelines (e.g., ICH, FDA, EMA), and industry best practices.Familiarity with safety databases (e.g., Argus, ARISg) and safety reporting tools.Strong attention to detail and accuracy in data collection, review, and documentation.Proficiency in using pharmacovigilance software, Microsoft Office Suite, and other relevant computer applications. .