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Mex - Pharmacovigilance Reporting (Associate & Senior Associate)

2+ years
Not Disclosed
10 April 25, 2025
Job Description
Job Type: Full Time 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: MEX - Pharmacovigilance Reporting (Associate & Senior Associate)
Location: Mexico, Homeworking (Mexico City – Hybrid, 3 days office-based)
Job Type: Full-time
Start Date: 23 April 2025
Closing Date: 23 May 2025


About the Company:

ICON plc is a world-leading healthcare intelligence and clinical research organization. Known for fostering an inclusive and innovative environment, ICON is dedicated to shaping the future of clinical development. With a global presence, the company drives excellence in healthcare solutions by investing in high-performing talent and supporting employee growth and well-being.


Job Overview:

ICON is seeking a Pharmacovigilance Reporting Associate/Senior Associate (Leader Role) to join its diverse and dynamic pharmacovigilance team. The role involves preparing and reviewing safety reports for clinical trials and post-marketing activities, ensuring regulatory compliance, and managing safety data to support patient safety.


Key Responsibilities:

  • Prepare and review safety reports, including periodic safety updates and individual case safety reports, with a focus on regulatory compliance and accuracy

  • Analyze adverse event data from clinical trials and post-marketing sources

  • Stay updated with regulatory requirements and pharmacovigilance reporting standards

  • Collaborate with internal teams such as clinical, regulatory, and data management to obtain essential data and resolve reporting issues

  • Ensure timely submission of safety reports to sponsors and regulatory authorities


Requirements:

For Associate Role:

  • Bachelor’s degree in life sciences, pharmacy, or a related discipline

  • Prior experience in pharmacovigilance or drug safety

  • Solid understanding of safety reporting procedures and regulations

  • Strong attention to detail with proven ability to review and compile complex safety reports

  • Effective communication and collaboration skills

  • Ability to work under pressure and manage multiple priorities

For Senior Associate Role:

  • Same qualifications as Associate, plus:

  • Proven experience in leading pharmacovigilance projects or studies

  • Advanced organizational and leadership skills

  • Demonstrated ability to manage large-scale safety reporting tasks independently


What ICON Offers:

  • Competitive salary

  • Annual leave entitlements and flexible benefits

  • Country-specific health insurance and retirement planning options

  • Global Employee Assistance Programme (LifeWorks)

  • Life assurance

  • Optional benefits: childcare vouchers, gym memberships, bike schemes, travel subsidies, health assessments

  • Commitment to inclusion, diversity, accessibility, and employee well-being