Drug Safety Coordinator

Drug Safety Coordinator / Medical Information Coordinator

Location: US or Canada (Flexibility for remote)

Position Summary

The Drug Safety Coordinator 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 Drug Safety Coordinator 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 in writing and/or by phone 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
• Willingness to spend up to 50% per day on the phone
• Fluency in French (both written & oral) strongly preferred
• Doctor, Nursing or Pharmacist background required

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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.