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Senior Pharmacovigilance Associate

Pharmiweb
4-7 years
preferred by company
10 Jan. 16, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Senior Pharmacovigilance Associate – Post Marketing (FSP, Sponsor-Dedicated)

Company: ICON Strategic Solutions
Location: Brazil (Remote / Home-Based)
Employment Type: Full-Time
Experience Level: Senior / Experienced
Start Date: 24 December 2025
Application Deadline: 15 January 2026
Salary: Competitive (Commensurate with Experience)


About ICON Strategic Solutions

ICON plc is a globally recognized healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies in accelerating clinical development and post-marketing safety worldwide. ICON fosters a culture of innovation, inclusion, and scientific excellence, with patient safety at the core of everything we do.


Role Overview

ICON Strategic Solutions is seeking a Senior Pharmacovigilance Associate – Post Marketing to support sponsor-dedicated pharmacovigilance operations within a Functional Service Provider (FSP) model. In this role, you will play a key part in ensuring regulatory-compliant safety surveillance for marketed products while contributing to signal detection, risk management, and continuous process improvement.

This position is ideal for an experienced pharmacovigilance professional looking to grow within a global, remote-first environment.


Key Responsibilities

Pharmacovigilance Operations

  • Lead the collection, processing, and evaluation of adverse event and safety reports in accordance with global regulatory requirements and internal SOPs

  • Ensure timely and accurate case processing, follow-up, and submission across global safety databases

Safety Data Analysis & Reporting

  • Perform detailed analysis and interpretation of safety data to identify trends, risks, and potential safety signals

  • Prepare, review, and contribute to periodic safety reports including PSURs, PBRERs, and other post-marketing regulatory documents

Cross-Functional Collaboration

  • Partner with medical, clinical, and regulatory teams to assess clinical relevance of safety data and support benefit-risk evaluations

  • Contribute to risk management activities and signal escalation discussions

Systems, Compliance & Inspections

  • Maintain the integrity and quality of pharmacovigilance databases and documentation

  • Support pharmacovigilance audits, inspections, and health authority interactions

  • Ensure inspection readiness and ongoing compliance with ICH, GVP, FDA, EMA, and local regulatory requirements

Mentorship & Process Improvement

  • Provide guidance and mentoring to junior pharmacovigilance associates

  • Stay current with evolving global PV regulations and industry best practices to enhance operational excellence


Qualifications & Experience Required

Education

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related discipline

  • Advanced degree or pharmacovigilance certification is preferred

Experience

  • Minimum 4–7 years of hands-on experience in pharmacovigilance or drug safety within pharmaceutical, biotech, or CRO environments

  • Demonstrated experience in post-marketing pharmacovigilance activities

  • Prior experience in sponsor-dedicated or FSP models is an advantage

Skills & Competencies

  • Strong knowledge of global pharmacovigilance regulations and reporting standards

  • Proven expertise in adverse event case processing, signal detection, and safety reporting

  • Proficiency with pharmacovigilance databases and Microsoft Office applications

  • Excellent analytical, organizational, and problem-solving skills

  • Ability to work independently in a fast-paced, remote environment

  • Strong communication and collaboration skills

  • Fluency in English (written and spoken)


Why Join ICON?

  • Fully remote, home-based opportunity in Brazil

  • Competitive compensation and country-specific benefits

  • Comprehensive health, wellness, and work-life balance programs

  • Global exposure to sponsor-dedicated pharmacovigilance projects

  • Career development, learning, and internal mobility opportunities

  • Inclusive, performance-driven culture committed to diversity and belonging


ICON is an equal opportunity employer committed to creating a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, religion, gender, age, disability, or any other legally protected status.


Apply now via thepharmadaily.com to advance your career in post-marketing pharmacovigilance with a global clinical research leader.