Pharmacovigilance Analyst (Mid-level)
Farmoquimica S/A
full-time
Posted on:
Location Type: Office
Location: Rio de Janeiro • Brazil
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Tech Stack
About the role
- Receive, evaluate, qualify and investigate individual safety cases (ICSRs), including serious and non-serious adverse events.
- Contact reporters to collect supplementary information and ensure completeness and quality of reports.
- Determine causality using recognized methodologies, ensuring technical consistency in decision-making.
- Monitor scientific literature and update safety systems in accordance with compliance requirements.
- Submit cases to ANVISA and other regulatory authorities within established deadlines.
- Prepare technical and supporting documentation for registration and post-registration activities, aligned with current regulations.
- Prepare and review periodic safety reports (PSURs, RMPs and PBRERs).
- Participate in internal audits, self-inspections and compliance assessments, ensuring alignment with pharmacovigilance guidelines.
- Support the implementation and maintenance of the local Pharmacovigilance System, including monitoring of vendors and partners.
- Track regulatory updates and assess impacts on products and internal processes.
- Draft, review and monitor Pharmacovigilance Agreements (SDEA) with national and international partners.
- Interface with Regulatory Affairs, Quality, Customer Service (SAC), medical teams and external partners on corrective and preventive actions.
- Develop and deliver internal training on pharmacovigilance workflows, responsibilities and requirements.
- Actively contribute to strengthening a patient safety culture within the organization.
Requirements
- Degree in Pharmacy, Biomedicine or related fields
- Experience: 3 to 5 years in Pharmacovigilance
- Practical knowledge of Pharmacovigilance Good Practices (ANVISA / ICH)
- Knowledge of national and international pharmacovigilance regulations (ANVISA, EMA, ICH, FDA)
- Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP)
- Experience with electronic safety systems (UltraVig/UltraCOS, Argus, ArisG or similar)
- Causality assessment techniques (WHO-UMC, Naranjo)
- Technical and advanced English
Benefits
- On-site meals
- Meal allowance
- Health insurance (Bradesco or Unimed)
- Dental care (Odontoprev)
- Gym subsidy (Wellhub/Gympass)
- Payroll-deductible loans
- Profit-sharing (PLR)
- Pet insurance
- Employee discount club
- Private pension plan
- Dasa+ Saúde program
- Free medications
- Pharmacy card
- Optical allowance
- Education assistance
- Life insurance
- Childcare assistance
- Shuttle bus from various regions
- And much more!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
PharmacovigilanceCausality assessment techniquesGood Clinical PracticeGood Pharmacovigilance PracticesTechnical documentation preparationPeriodic safety reports preparationRegulatory complianceSafety case evaluationAdverse event investigationInternal training development
Soft Skills
CommunicationInterpersonal skillsOrganizational skillsAnalytical thinkingAttention to detailTeam collaborationProblem-solvingLeadershipAdaptabilityCultural awareness
Certifications
Degree in PharmacyDegree in BiomedicinePharmacovigilance certification