Pharmacovigilance & Drug Safety ManagerLocation-India (Hybrid / Remote / Office based – as applicable)Experience-5–12 yearsEmployment Type-Full TimeRole OverviewWe are seeking an experienced Pharmacovigilance & Drug Safety Manager to oversee pharmacovigilance operations, safety surveillance, and regulatory compliance for pharmaceutical and healthcare clients across global markets.The role requires strong expertise in drug safety monitoring, adverse event reporting, signal detection, and global pharmacovigilance regulations. The candidate will work closely with cross-functional teams including regulatory affairs, clinical development, medical affairs, and data analytics teams to ensure patient safety and regulatory compliance.Key ResponsibilitiesPharmacovigilance OperationsManage end-to-end pharmacovigilance processes including case intake, triage, data entry, and processing of Individual Case Safety Reports (ICSRs).Ensure timely submission of adverse event reports to regulatory authorities in compliance with global reporting timelines.Maintain quality standards in safety case processing and documentation.Regulatory ComplianceEnsure compliance with global pharmacovigilance regulations including FDA, EMA, MHRA, and ICH guidelines.Support preparation and submission of safety reports including:Periodic Safety Update Reports (PSUR / PBRER)Development Safety Update Reports (DSUR)Risk Management Plans (RMP)Support internal and regulatory audits and inspections.Signal Detection & Safety SurveillanceConduct signal detection and safety surveillance activities using spontaneous reports, literature monitoring, and safety databases.Participate in signal evaluation, validation, and benefit-risk assessments.Assist in implementation of risk mitigation strategies.Safety Systems & Data AnalysisWork with pharmacovigilance safety databases such as Argus, ArisG, or similar systems.Perform coding using MedDRA and WHO Drug dictionaries.Support safety data analysis and trend monitoring.Cross-Functional CollaborationCollaborate with regulatory affairs, clinical teams, quality assurance, and medical affairs.Provide pharmacovigilance guidance to internal teams and external stakeholders.Participate in safety governance meetings and regulatory discussions.Process & DocumentationDevelop and maintain SOPs, work instructions, and safety documentation.Contribute to continuous improvement initiatives in pharmacovigilance processes.QualificationsBachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, or related field.8–12 years of experience in pharmacovigilance, drug safety, or regulatory compliance.Strong knowledge of global pharmacovigilance regulations and reporting requirements.Hands-on experience with ICSR processing and safety databases.Familiarity with MedDRA coding and signal management processes.Preferred SkillsExperience in global CRO or consulting environments.Exposure to safety data analytics or AI tools in pharmacovigilance.Experience supporting regulatory inspections and audits.Key CompetenciesDrug Safety SurveillanceGlobal Pharmacovigilance ComplianceRisk Management & Signal DetectionSafety Data AnalysisStakeholder CollaborationAttention to Detail & Regulatory Accuracy