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Senior Pharmacovigilance Associate (Administrative Role)

2+ years
Not Disclosed
10 March 21, 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

Senior Pharmacovigilance Associate (Administrative Role)
Company: ICON Plc
Location: Mexico, Homeworking
Salary: Competitive
Start Date: 17 Mar 2025
Closing Date: 16 Apr 2025
Job Type: Full-time
#LI-Remote

Position Summary:

The Senior Pharmacovigilance Associate will work in a Medical Call Center and handle all medical information duties, supporting clients in compliance with regulations, company SOPs, and project-specific agreements. The role includes taking or making follow-up calls related to drug products, quality complaints, and adverse events.

Key Responsibilities:

Medical Information & Call Handling:

  • Respond to and process medical information inquiries from HCPs, consumers, regulators, and internal colleagues.

  • Handle adverse events/reactions and product complaints per client agreements.

  • Triage incoming information based on regulatory requirements and SOPs.

  • Conduct adverse event follow-ups via phone or written communication.

Project Management:

  • Manage client projects, relationships, and project budgets.

  • Monitor and manage project-specific email accounts, faxes, and phone calls.

  • Triage incoming information to determine classification and timelines.

Database Management & Documentation:

  • Enter data into medical information databases, tracking systems, and project-specific forms ensuring accuracy.

  • Maintain a library of Standard Response Letters (SRLs) and Frequently Asked Questions.

  • Prepare Standard Response Letters, including conducting literature searches and article summaries.

Compliance & Safety Monitoring:

  • Identify Case Safety Reports (ICSRs) and product complaints, forwarding them to stakeholders within defined timelines.

  • Assist with safety database reconciliation and tracking systems.

  • Monitor and interpret global regulations related to medical information and pharmacovigilance.

Audit & Inspection Support:

  • Assist with regulatory agency inspections, client audits, and internal audits.

Team Collaboration:

  • Actively participate in multidisciplinary teams to achieve project and corporate goals.

  • Identify project issues and propose alternative strategies.

Requirements:

  • 2 years of experience in Pharmacovigilance.

  • Strong written and oral communication skills in English.

  • HCP (Nurse or Pharmacist) qualification.

  • Ability to work in a Medical Call Center with 80% of the time engaging with HCPs and patients.

What ICON Offers:

  • Competitive salary and benefits.

  • Various annual leave entitlements.

  • A range of health insurance offerings.

  • Competitive retirement plans for future financial security.

  • Access to LifeWorks Global Employee Assistance Programme for 24/7 support.

  • Flexible optional benefits based on country-specific needs.

Diversity & Inclusion at ICON:

ICON fosters a culture of inclusion and innovation, ensuring a workplace free from discrimination and harassment. Qualified applicants will be considered regardless of race, religion, gender identity, disability, or protected veteran status.