Senior Pharmacovigilance Associate

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Position Summary

The MI staff member will work in a Medical Call Center and is responsible for all medical information duties to support clients in compliance with applicable regulation, the company Standard Operation Procedures and project- specific operational agreements. The MI staff member will be trained to take calls or make follow-up calls regarding various drug products and their respective quality complaints, adverse events, etc.

Job Responsibilities

• Respond and process medical information inquiries from healthcare professional, consumers, regulators and internal colleagues, including inquiries related to adverse events/reactions and product complaints for Clients’ product(s), as per their agreement with ICON. 
• Triage information received based on regulatory requirements and applicable SOPs ensuring adverse events, product complaints and medical information queries are handled in a compliant manner.
• Complete adverse event follow-up by phone or in writing based on requirements for each Client and/or case.
• Prioritizing and complete multiple projects within established time frames.
• Managing client projects; including managing client relationships and project budgets
• Monitoring and managing project-specific email accounts, incoming faxes, and telephone calls. Preliminary triaging of incoming information to determine classification, priorities, and time frame for subsequent activities.
• Entering information for medical information inquiries into medical information databases, tracking systems and project- specific forms ensuing accurate data entry.
• Maintaining a library of responses to Frequently Asked Questions and of Standard Response Letters.
• Preparation of Standard Response letters, including conducting literature search, article summary etc.
• Responding to medical information inquiries within pre-determined timelines and constraints, requesting assistance from clients and safety physicians as appropriate.
• Identifying individual Case Safety Reports and technical product complaints and forwarding them to relevant stakeholders within pre-determined timelines.
• Assisting with or performing reconciliation of safety databases, safety tracking systems, medical information databases, product complaint database, and clinical databases.
• Monitoring and interpreting worldwide regulations pertaining to medical information and pharmacovigilance, providing regulatory expertise to colleagues and clients.
• Assisting with regulatory agency inspections, client audits, and internal audits.
• Participating as an active member of multidisciplinary terms to successfully achieve project and corporate goals. Identifying project issues and developing proposals for alternative strategies for discussion with superiors.
• Completing other appropriate duties as assigned by line manager that requires similar skills.

Requirements:

• Strong written & oral communication skills in English and Spanish
• Bachelor's degree: Doctor, Nursing, Pharmacist, (related to health

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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