Pharmacovigilance Expert

At Icon Plc, we're driven by a shared purpose: advancing and improving patients' lives through clinical research excellence. We foster a collaborative environment where talented individuals can thrive and make a meaningful impact.

We're seeking a skilled Pharmacovigilance Associate to join our dynamic team. As a key member, you'll play a critical role in delivering exceptional client service while ensuring regulatory compliance.

• 
  
• Respond to medical information inquiries from healthcare professionals, consumers, regulators, and internal colleagues, addressing adverse events/reactions, product complaints, and other concerns related to our clients' products.
  
• Triage incoming information based on regulatory requirements and standard operating procedures (SOPs), ensuring that adverse events, product complaints, and medical queries are handled in compliance with applicable regulations.
  
• Complete adverse event follow-ups via phone or written correspondence, as required for each client and case.
  
• Prioritize and manage multiple projects within established timelines, leveraging your organizational skills to ensure timely completion.
  
• Develop and maintain strong relationships with clients, providing exceptional project management and communication services.
  
• Accurately enter information into medical information databases, tracking systems, and project-specific forms to ensure data integrity.
  
• Maintain a library of responses to frequently asked questions and standard response letters.
  
• Prepare high-quality standard response letters, conducting literature searches and article summaries as necessary.
  
• Respond to medical information inquiries within predetermined timelines, collaborating with clients and safety physicians as needed.
  
• Identify individual Case Safety Reports and technical product complaints, forwarding them to relevant stakeholders within designated timeframes.
  
• Assist with reconciliations of safety databases, safety tracking systems, medical information databases, product complaint database, and clinical databases.
  
• Stay up-to-date on worldwide regulations regarding medical information and pharmacovigilance, providing regulatory expertise to colleagues and clients.
  
• Support regulatory agency inspections, client audits, and internal audits.
  
• Contribute as an active member of multidisciplinary teams to achieve project and corporate goals, identifying project issues and proposing alternative strategies for discussion with superiors.
  

• 
  
• Exceptional written and verbal communication skills in English
  
• Bachelor's degree in a relevant field (e.g., Doctor, Nursing)
  
• A minimum of one year of experience in customer service, preferably in a call center environment
  

We offer competitive salary packages and a comprehensive range of benefits to support employees' well-being and career growth. Join our team and discover a work environment where you can grow professionally and personally.

Icon Plc is an equal opportunities employer committed to fostering an inclusive culture that values diversity and promotes employee satisfaction.