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Bra - Pharmacovigilance Reporting (Associate & Senior Associate)

0-2 years
Not Disclosed
10 April 7, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title: Pharmacovigilance Reporting Associate / Senior Associate (Leader Role)

Company: ICON plc
Location: São Paulo, Brazil (Hybrid – Office-based an average of 3 days/week)
Job Type: Full-Time


Job Overview

ICON plc is hiring Pharmacovigilance Reporting Associates and Senior Associates to support clinical and post-marketing safety reporting activities. The role is essential for ensuring accurate safety data submissions in compliance with regulatory requirements. The Senior Associate position includes leadership responsibilities over projects or studies.


Key Responsibilities

  • Prepare and review safety reports (PSURs, ICSRs) ensuring compliance with applicable regulations.

  • Collect and analyze adverse event data from clinical trials and post-marketing sources.

  • Maintain current knowledge of global pharmacovigilance reporting regulations.

  • Collaborate cross-functionally with clinical, regulatory, and data teams.

  • Ensure timely submissions to sponsors and regulatory authorities.


Qualifications

For Associate Level:

  • Bachelor’s degree in Life Sciences, Pharmacy, or related field.

  • Experience in pharmacovigilance or drug safety.

  • Understanding of safety reporting processes and regulatory frameworks.

  • Strong attention to detail and organizational skills.

  • Excellent teamwork and communication abilities.

  • Ability to work under pressure and manage multiple tasks effectively.

For Senior Associate Level:

  • All requirements from Associate level.

  • Proven leadership experience in managing projects or studies.

  • Advanced communication and team leadership skills.


Work Model

  • Hybrid role: On-site presence required 3 days per week in São Paulo, Brazil.


Benefits Offered by ICON

  • Competitive salary and country-specific benefits

  • Paid annual leave entitlements

  • Health insurance for employees and families

  • Retirement planning offerings

  • 24/7 global Employee Assistance Programme (LifeWorks)

  • Life assurance

  • Optional flexible benefits (e.g., gym memberships, childcare vouchers, health assessments)

  • Commitment to diversity, inclusion, and accessibility in the workplace


Diversity & Inclusion Statement

ICON is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status.

If you need accommodation during the application process due to a medical condition or disability, ICON will provide reasonable assistance.