Job Information
ICON Clinical Research Pharmacovigilance Reporting Associate (French or German or Italian language) in Sofia, Bulgaria
Pharmacovigilance Reporting Associate - languages
ICON 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 development.
The Role:
This PV Reporting Associate 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 new hire will be trained to take calls or make follow-up calls regarding various drug products and their respective quality complaints, adverse events, etc.
Key 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:
Be a healthcare professional (Doctor, Nurse, Pharmacist, CRA)
Strong written & oral communication skills in English
Language skills with French/German/Italian (any of these
Experience of clinical trials advantageous.
What 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.
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, colour, 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 or submit a request here (https://careers.iconplc.com/reasonable-accommodations)
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply