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.
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