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Soulan Recursos Humanos

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Senior Pharmacovigilance Analyst

AnalystAnalystFull TimeRemoteSeniorTeam 51-200Since 1988H1B No SponsorCompany SiteLinkedIn

Location

Brazil

Posted

6 days ago

Salary

0

Seniority

Senior

Bachelor DegreePortugueseEnglish

Job Description

Senior Pharmacovigilance Analyst

Soulan Recursos Humanos

• Perform evaluation and monitoring of safety data for marketed medicines, ensuring compliance with national and international pharmacovigilance regulations. • Conduct safety assessments, trend analyses, signal detection and support the preparation of product benefit–risk assessments. • Support the development, review and implementation of procedures, work instructions and workflows related to the Pharmacovigilance System. • Participate in strategic projects related to new product development, contributing safety assessments and defining pharmacovigilance processes. • Work with external partners and partner companies to ensure technical alignment, information exchange and compliance with pharmacovigilance agreements. • Contribute to benefit–risk assessments, safety analyses and signal detection activities. • Support audits, regulatory inspections and due diligence processes related to the area. • Participate in the structuring and continuous improvement of pharmacovigilance processes, promoting quality, traceability and data reliability. • Monitor timelines, deliverables and requests related to projects under your responsibility.

Job Requirements

  • Education: Bachelor’s degree in Pharmacy or related Health Sciences field
  • Experience: Experience in assessing and managing safety cases and in drug safety monitoring activities
  • Experience in project management, implementation or process improvement
  • Experience interacting with multidisciplinary teams and external partners
  • Knowledge of national and international regulations applicable to Good Pharmacovigilance Practices (RDC 406/2020, GVP, ICH and other applicable standards)
  • Advanced English – conversational

Benefits

  • Health insurance
  • Meal allowance
  • Transportation allowance
  • Life insurance

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