Job
Description
As a Pharmacovigilance Manager at our company, you will play a crucial role in leading and mentoring the global case processing team. Your responsibilities will include: - Leading and mentoring the global case processing team to foster a collaborative and high-performance culture. - Overseeing daily operations to ensure timely and accurate processing of adverse event reports. - Conducting regular performance evaluations and providing feedback to team members. - Managing the intake and triage of adverse event reports to ensure compliance with internal and external regulatory requirements. - Evaluating adverse event reports for quality and completeness, making determinations on seriousness, causality, and expectedness. - Collaborating with cross-functional teams to resolve complex cases and support risk assessment activities. - Ensuring adherence to pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA standards. - Developing and implementing corrective and preventive action (CAPA) plans in response to audit findings, inspections, and internal deviations. - Leading internal and external audits, preparing teams for inspections, and ensuring readiness. - Identifying opportunities for process optimization and implementing best practices in case processing. - Monitoring key performance indicators (KPIs) and preparing reports for management on case processing metrics and compliance activities. - Staying current with industry trends and regulatory changes, adjusting processes accordingly. - Developing training materials and conducting training sessions for staff on pharmacovigilance procedures and regulatory compliance. - Fostering a culture of continuous learning and professional development within the team. - Providing inputs into responses to Medical inquiries from regulatory authorities or health care professionals on safety issues coming from MIRF (Medical Information Request Form). - Supporting the development and revision of Standard Operating Procedures (SOPs), work instructions, templates, and training guidance materials. - Leading and facilitating comprehensive training for all ICSR Processing team and ensuring adherence to best practices and regulatory standards. - Providing comprehensive support for pharmacovigilance-related projects and activities, as delegated by the Department Head/Designee, to ensure operational efficiency and compliance. Required Skills: - Pharmacovigilance Regulations (ICH, FDA, EMA) Advanced - Individual Case Safety Report (ICSR) Processing Advanced - Medical Assessment & BenefitRisk Thinking Intermediate - Coding Standards (MedDRA, WHO Drug) Advanced - Safety Database Management (Argus, ArisG, Veeva Vault Safety) Advanced - Global Reporting Requirements Advanced - Data Integrity & ALCOA+ Principles Advanced - SOPs/WIs/Templates Authoring Advanced - Quality Management & CAPA (Root Cause Analysis, FMEA) Advanced - Audit & Inspection Readiness Expert - Deviation Management & QMS Advanced - Compliance Monitoring & Controls Advanced - Risk Management (ICH Q9 principles) Advanced - Operational Excellence Advanced - Leadership and People Management Advanced Qualifications Required: - Doctor of Pharmacy - Minimum of 8 years of experience in pharmacovigilance, with at least 5 years in a managerial role. As an equal opportunity employer, we do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. As a Pharmacovigilance Manager at our company, you will play a crucial role in leading and mentoring the global case processing team. Your responsibilities will include: - Leading and mentoring the global case processing team to foster a collaborative and high-performance culture. - Overseeing daily operations to ensure timely and accurate processing of adverse event reports. - Conducting regular performance evaluations and providing feedback to team members. - Managing the intake and triage of adverse event reports to ensure compliance with internal and external regulatory requirements. - Evaluating adverse event reports for quality and completeness, making determinations on seriousness, causality, and expectedness. - Collaborating with cross-functional teams to resolve complex cases and support risk assessment activities. - Ensuring adherence to pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA standards. - Developing and implementing corrective and preventive action (CAPA) plans in response to audit findings, inspections, and internal deviations. - Leading internal and external audits, preparing teams for inspections, and ensuring readiness. - Identifying opportunities for process optimization and implementing best practices in case processing. - Monitoring key performance indicators (KPIs) and preparing reports for management on case processing metrics and compliance activities. - Staying current
