Pharmacovigilance Associate (Administrative role)

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:

• 1 year of experience in Pharmacovigilance
• Strong written & oral communication skills in English
• HCP (Nurse or Pharmacist)
• Candidate should understand this is a role in a Medical Call center: you will be 80% of the time speaking to HCPs and patients.

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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.

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.