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Pharmacovigilance Analyst (Mid-level)
Daiichi Sankyo Brasil LtdaAnalista de Farmacovigilância na Daiichi Sankyo, farmacêutica japonesa de medicamentos inovadores. Preparando submissões regulatórias, gerenciando relatórios, treinamentos, auditorias e casos de eventos adversos.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Pharmacovigilance activities, including regulatory filings, training material preparation, and compliance with applicable regulations. Proficient in managing adverse event reports and supporting departmental improvement initiatives.
Highest-signal resume keywords
Pharmacovigilance ActivitiesRegulatory FilingsTraining Material PreparationAdverse Event ReportingCAPA Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Pharmacy DegreeRegulatory ComplianceDocument ReviewStandard Operating ProceduresPharmacovigilance Reporting
Soft Skills
CommunicationCollaborationTraining Delivery
Industry Keywords
PharmacovigilanceRegulatory AuthoritiesAdverse Event ReportsCAPA Action PlansRegulatory Intelligence
About the role
Key responsibilities & impact- Support the preparation or review of Pharmacovigilance training materials
- Prepare, review and submit regulatory filings or send pharmacovigilance documents to partners
- Manage requests and timelines for pharmacovigilance reports to regulatory authorities and partners
- Draft, review and maintain Forms, Reference Lists, Work Instructions and Standard Operating Procedures for the department
- Interact with headquarters, other affiliates and partners regarding adverse event reports, database configurations, reports and pharmacovigilance plans
- Deliver trainings and manage pharmacovigilance training records/evidence
- Support approval of projects and/or third‑party contracts for the DSBR portfolio, with responsibility for reporting pharmacovigilance cases
- Support regulatory intelligence for Pharmacovigilance by monitoring updates to applicable regulations and assessing impacts to the company
- Support translation of package inserts/labels for the DSBR portfolio
- Support management of CAPA action plans owned by the area
- Provide support during pharmacovigilance audits, when required
- Act as backup for operational activities
- Serve as backup to process individual pharmacovigilance cases in the required formats and within established timelines
- Propose and contribute to departmental improvement and excellence projects
Requirements
What you’ll need- Bachelor's degree in Pharmacy
- Advanced English
- Experience in pharmacovigilance activities
Benefits
Comp & perks- Culture of collaboration and trust
- Inclusive environment and support for diversity
- Affirmative action vacancy for Black and mixed‑race candidates
- Position also open to persons with disabilities (PwD)