02/25/2025 updated
100 % available
Experienced Pharmacovigilance Manager with 7 Years in Safety Management
Petrovaradin, Serbia
Only remote
Master of Biology (Botany)Corrective and Preventive Action (CAPA)ComplianceDatabasesPharmacovigilanceStandard Operating ProcedureManagement SystemsProject ManagementMedDRAQuality Management
Pharmacovigilance Management
Extensive experience in pharmacovigilance practices, including developing safety management plans, standard operating procedures (SOPs), and operational guidelines.
Project Management
Proven ability to lead projects, manage resources, and ensure high-quality deliverables aligned with strategic business goals in the pharmaceutical industry.
Regulatory Compliance
Strong knowledge of regulatory standards and quality compliance in the pharmaceutical sector, including audits, inspections, and implementation of Corrective and Preventive Actions (CAPA).
Case Processing
Expertise in processing Individual Case Safety Reports (ICSRs) from various sources, ensuring compliance with applicable regulations and timelines.
Quality Management Systems
Proficiency in managing Quality Management System activities, developing standard operating procedures, and maintaining compliance with PV systems.
Medical Coding
Skilled in MedDRA and WHO coding for accurate classification of adverse events and medical information in pharmacovigilance databases.
Data Analysis and Reporting
Capability to generate and analyze database outputs and reports, including data for monthly reporting to clients.
Extensive experience in pharmacovigilance practices, including developing safety management plans, standard operating procedures (SOPs), and operational guidelines.
Project Management
Proven ability to lead projects, manage resources, and ensure high-quality deliverables aligned with strategic business goals in the pharmaceutical industry.
Regulatory Compliance
Strong knowledge of regulatory standards and quality compliance in the pharmaceutical sector, including audits, inspections, and implementation of Corrective and Preventive Actions (CAPA).
Case Processing
Expertise in processing Individual Case Safety Reports (ICSRs) from various sources, ensuring compliance with applicable regulations and timelines.
Quality Management Systems
Proficiency in managing Quality Management System activities, developing standard operating procedures, and maintaining compliance with PV systems.
Medical Coding
Skilled in MedDRA and WHO coding for accurate classification of adverse events and medical information in pharmacovigilance databases.
Data Analysis and Reporting
Capability to generate and analyze database outputs and reports, including data for monthly reporting to clients.
Experience
Professional experience5 - 10 years
Freelancer since2025
Languages
EnglishFluentSerbianNative speaker
Project history
Leading pharmacovigilance projects, managing specialists and team leaders, conducting literature screenings, and ensuring compliance with regulatory standards.
Managed contracted activities for clients, ensured regulatory compliance, and supported project directors in leadership management.
Provided support to project teams, processed safety reports, and performed ICSR follow-ups while managing various pharmacovigilance tasks.
Certificates
Advanced MedDRA Coding
MedDRA MSSO2024
Essentials of pharmacovigilance communication
Uppsala Monitoring Centre2023
Getting Started with MedDRA
MedDRA MSSO2023