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Bra - Pharmacovigilance Reporting (Associate & Senior Associate)

0-2 years
Not Disclosed
10 April 1, 2025
Job Description
Job Type: Remote 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
Employer: ICON Plc
Location: Brazil (Homeworking, Office-based in São Paolo 3 days per week)
Salary: Competitive
Start Date: 28 Mar 2025
Closing Date: 27 Apr 2025

Job Description

ICON plc is a leading healthcare intelligence and clinical research organization. We are looking for a Pharmacovigilance Reporting Associate/Senior Associate (Leader role) to join our diverse and dynamic team. The role focuses on preparing and reviewing safety reports related to clinical trials and post-marketing activities, ensuring regulatory compliance and supporting patient safety.

Responsibilities:

  • Preparation & Review: Ensure accurate and timely preparation of safety reports, including periodic safety updates and individual case safety reports, adhering to regulatory standards.

  • Data Collection & Analysis: Collect and analyze adverse event data from clinical trials and post-marketing sources to prepare comprehensive safety reports.

  • Regulatory Compliance: Stay up-to-date on regulatory requirements and industry best practices related to pharmacovigilance reporting.

  • Collaboration: Work with cross-functional teams (clinical, regulatory, data management) to resolve reporting issues.

  • Timely Submission: Submit safety reports to regulatory authorities and sponsors within deadlines.

Requirements for Associate Role:

  • Education: Bachelor’s degree in life sciences, pharmacy, or a related field.

  • Experience: Knowledge of pharmacovigilance or drug safety and safety reporting processes.

  • Skills: Attention to detail, organizational skills, and the ability to work within multidisciplinary teams.

  • Other: Ability to manage multiple tasks in a fast-paced, regulated environment.

Requirements for Senior Associate Role:

  • Education: Bachelor’s degree in life sciences, pharmacy, or a related field.

  • Experience: Strong background in pharmacovigilance or drug safety with experience leading projects or studies.

  • Skills: Attention to detail, organizational skills, and communication skills.

  • Other: Ability to manage multiple tasks and prioritize in a fast-paced environment.

Benefits:

  • Annual Leave: Various leave entitlements.

  • Health Insurance: A range of offerings for you and your family.

  • Retirement Planning: Competitive offerings for future savings.

  • Employee Assistance: 24-hour access to a global network of support professionals.

  • Life Assurance: Included for added security.

  • Other Benefits: Country-specific options such as childcare vouchers, gym memberships, travel passes, etc.

Company Culture:

ICON fosters a diverse and inclusive environment where innovation and excellence are prioritized. We are committed to providing equal employment opportunities for all qualified applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Application:

Interested in the role, but unsure if you meet all the requirements? We encourage you to apply regardless.