Senior Pharmacovigilance Analyst

Jobtailor; Paulínia; Presencial; BRL 90 000 - 150 000; Tempo integral

Resumo da oferta

Jobtailor is seeking a Pharmacovigilance professional in Brazil to manage end-to-end safety reporting, coding, and regulatory submissions. You will perform causality and seriousness assessments, SUSAR submissions, and data reconciliations, while developing SOPs and training staff.

The role requires a pharmacy/biomedicine degree, PV experience, and strong English. You will ensure compliance with ICH/ANVISA and support audits and quality controls.

Qualificações

• Bachelor’s degree in Pharmacy, Biomedicine, or a related field.
• Experience in pre- and post-marketing pharmacovigilance.
• Knowledge of MedDRA and WHODrug coding.
• Experience processing and submitting adverse events to regulatory authorities, as well as QC.
• Experience conducting searches and analyses of scientific literature.
• Experience preparing and reviewing SOPs, work instructions, and Risk Management and Risk Minimization Plans.
• Advanced English proficiency preferred.

Responsabilidades

• End-to-end processing of safety reports: triage, data entry, narrative writing, follow-up, and case closure.
• Support causality, seriousness, and expectedness assessments, SUSAR submission and tracking.
• Submit adverse event reports to regulatory authorities as applicable.
• Perform periodic reconciliations between eCRFs and databases.
• Prepare and update Safety Management Plans and safety reports (DSURs, periodic reports, Ethics Committee reports, line listings).
• Conduct QC reviews and support deviations and CAPAs.
• Prepare Risk Management Plans and Risk Minimization Plans.
• Ensure SOP compliance and support audits, inspections, and training.
• Develop and review SOPs and quality controls.
• Conduct internal and external pharmacovigilance training.
• Ensure compliance with ICH E2A/E2B/E6 R2/R3, ANVISA regulations, and sponsor requirements.
• Support department management in fulfilling all activities.

Conhecimentos

Pharmacovigilance Experience

MedDRA Coding

WHODrug Coding

Regulatory Submissions

SOP Development

Formação académica

Bachelor’s degree in Pharmacy/ Biomedicine or related field

Ferramentas

ECRFs

Safety Databases

Descrição da oferta de emprego

• • Responsible for the end-to-end processing of safety reports, including triage, data entry, narrative writing, follow-up, and case closure, as well as MedDRA and WHODrug coding in eCRFs and/or safety databases
• • Support causality, seriousness, and expectedness assessments, as well as SUSAR submission and tracking
• • Responsible for submitting adverse event reports to regulatory authorities, as applicable
• • Perform periodic reconciliations between eCRFs and databases
• • Prepare and update Safety Management Plans and safety reports, such as DSURs, periodic reports, Ethics Committee reports, and line listings
• • Conduct quality control (QC) reviews and support the management of deviations and CAPAs
• • Prepare Risk Management Plans (RMPs) and Risk Minimization Plans (RMinPs)
• • Ensure compliance with SOPs, work instructions, and regulatory requirements, providing support for audits, inspections, and pharmacovigilance training
• • Develop and review SOPs, work instructions, and quality controls
• • Conduct internal and external pharmacovigilance training
• • Ensure compliance with ICH E2A, E2B, E6 (R2/R3), applicable ANVISA regulations, and sponsor contractual requirements
• • Support department management in fulfilling all required activities and demands

Requirements

• Bachelor’s degree in Pharmacy, Biomedicine, or a related field
• Experience in pre- and post-marketing pharmacovigilance
• Knowledge of MedDRA and WHODrug coding
• Experience processing and submitting adverse events to regulatory authorities, as well as conducting quality control
• Experience conducting searches and analyses of scientific literature
• Experience preparing and reviewing SOPs, work instructions, and Risk Management and Risk Minimization Plans
• Advanced English proficiency preferred

Core Competencies

Demonstrates expertise in pharmacovigilance processes, including safety report management, regulatory submissions, and compliance with ICH guidelines. Proficient in MedDRA and WHODrug coding, with a strong focus on quality control and risk management.

Highest-signal resume keywords

• Pharmacovigilance Experience
• MedDRA Coding
• WHODrug Coding
• Regulatory Submissions
• SOP Development

Hard Skills

• Safety Report Processing
• Data Entry
• Narrative Writing
• Quality Control
• Risk Management Plans
• Adverse Event Reporting
• Causality Assessment
• Periodic Reconciliation
• SUSAR Submission
• Scientific Literature Analysis

Soft Skills

• Attention to Detail
• Communication Skills
• Training Ability

Industry Keywords

• ICH E2A
• ICH E2B
• ICH E6 (R2/R3)
• ANVISA Regulations
• Pharmacovigilance Training

Tools & Technologies

• ECRFs
• Safety Databases