Manager, Pharmacovigilance Operations | ICSR Operations

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 AdvancedQualifications 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

Keyskills :
EMAArisGFMEAOperational ExcellencePharmacovigilance Regulations ICHFDAIndividual Case Safety Report ICSR ProcessingMedical AssessmentBenefitRisk ThinkingCoding Standards MedDRAWHO DrugSafety Database Management ArgusVeeva Vault SafetyGlobal Re