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AI Summary

Provide virtual clinical support to healthcare professionals and patients regarding drug and medical device information. Document adverse events, product quality complaints, and maintain compliance with FDA and HIPAA regulations.

Job Purpose/Overview:

A frontline specialist responsible for delivering virtual or telephonic support to clients, customers, patients, and/or healthcare professionals in a robust clinical dialogue. The specialist serves as a primary resource to provide drug and medical device product information.

Job Duties & Responsibilities:

  • Maintain excellent quality and productivity standards for all client programs; adhere to program scripts and guidelines.
  • Completely and accurately identify, address, and document all Information Requests, Adverse Events (AEs), Product Quality Complaints (PQCs), Special Situations, and other reportable information in compliance with Inizio, client requirements, and other guidelines and regulations.
  • Conduct study compliance calls to volunteers enrolled in clinical/medical research trials.
  • Enroll participants in educational seminars.
  • Provide patient support to patients enrolled in Patient Support Programs.
  • Collect demographic data and disposition information for product, sample, and literature fulfillment.
  • Accurately collect information required by individual programs and correctly capture information in designated databases.
  • Exhibit effective communication, customer service, and telephone support skills.
  • Communicate with callers in an empathetic manner while explaining medical terminology in a clear and understandable way, as appropriate.
  • Demonstrate flexibility by supporting administrative and other business-related duties as required to meet operational needs.
  • Adhere to all company policies, Standard Operating Procedures, and compliance requirements.
  • Maintain knowledge of current FDA regulations, pharmacovigilance requirements, and applicable healthcare compliance standards.
  • Safeguard patient privacy and confidentiality in accordance with the Health Insurance Portability and Accountability Act (HIPAA), applicable data privacy legislation, and company information security policies.
  • Conduct all activities in compliance with applicable U.S. FDA requirements, HIPAA Privacy and Security Rules, client requirements, company Standard Operating Procedures, and applicable Philippine regulations.
  • Maintain a secure and confidential home-working environment with reliable internet connectivity and appropriate business continuity arrangements.
  • Possess effective organizational skills, including the ability to manage multiple priorities and projects simultaneously. 

Leadership Responsibilities:

  • Understands how own contribution contributes to results.
  • Understands what the organization delivers and our position within a global context.
  • Builds a network of useful contacts to help get things done more efficiently.
  • Is proactive and anticipatory with solutions to problems in the business.
  • Seeks to stretch own capability and is willing to operate outside of comfort zones.


Requirements & Qualifications:

  • Current registration and good standing with the Professional Regulation Commission (PRC) and the Philippine Board of Nursing (or other applicable Philippine healthcare professional regulatory board), as required by the client program.
  • Knowledge of United States healthcare systems, medicines regulation, and pharmacovigilance requirements preferred.
  • Experience in Medical Information, Pharmacovigilance, Patient Support Program, healthcare call centers, or related pharmaceutical industry roles preferred.
  • Excellent verbal, written, and listening communication skills.
  • Demonstrated proficiency in spoken and written English, with the ability to communicate professionally with U.S.-based healthcare professionals, patients, caregivers, and consumers.
  • Proficiency in Microsoft Office applications (Outlook, Word, Excel, PowerPoint, and Teams), business applications, and contact center technologies.
  • Ability to maintain a secure remote work environment and comply with company information security requirements.
  • Ability and willingness to work schedules that support U.S. business operations, including evenings, overnight shifts, weekends, and holidays, as required.

Physical Requirements:

  • Ability to lift, carry and otherwise move up to 25 pounds
  • Ability to sit, stand or walk for various lengths of time throughout the day
  • Ability to communicate effectively with clients and co-workers
  • Ability to proficiently operate computer hardware and software on a daily basis
  • Ability to effectively operate computers, telephony systems, standard office equipment, and business applications.
  • Ability to work remotely in a secure work environment and, where required, travel for business purposes.

Job Levels:

  • N/A or Not Listed

Our Leadership Commitments:

The Commitments are promises that our senior leaders are making about how we will behave; how we will interact with the people around us, and the kind of culture we want to work together to create:

 

Employment Equity

Inizio Engage is committed to providing equal employment opportunities to all applicants and employees. Employment decisions are based on qualifications, merit, business needs, and job requirements. We are committed to maintaining a workplace free from unlawful discrimination, harassment, and retaliation in accordance with applicable laws in the Philippines and other applicable jurisdictions.

 

Reasonable Accommodation

Inizio Engage is committed to providing reasonable accommodation to qualified applicants and employees with disabilities in accordance with applicable laws in the Philippines and company policy. Accommodation requests will be considered on a case-by-case basis

 

Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

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