Pharmacovigilance Associate

Pharmacovigilance AssociateICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentPosition 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- 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:- 1 year of experience in Pharmacovigilance- Strong written & oral communication skills in English- HCP (Nurse or Pharmacist)- #LI-Remote- #LI-FP1What ICON can offer you:- Our success depends on the quality of our people.That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.- In addition to your competitive salary, ICON offers a range of additional benefits.Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.- Our benefits examples include:- Various annual leave entitlements- A range of health insurance offerings to suit you and your family's needs.- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.- Life assurance- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.Visit ourcareers siteto read more about the benefits ICON offers.