Operation Specialist1 at IQVIA

Dalian, Liaoning, China

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Clinical ResearchIndustries

Requirements

Ability to perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs)
Knowledge of AE coding, past medical history, concomitant medications, expectedness/listedness, causality assessment, and other medical information
Understanding of applicable regulations, guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines
Problem-solving capabilities
Ability to demonstrate 100% compliance with people practices, processes, regulations, SOPs, and internal guidelines

Responsibilities

Prioritize and complete assigned trainings on time
Process safety data according to applicable regulations, guidelines, SOPs, and project requirements
Collect and track incoming Adverse Events (AEs)/endpoint information
Determine initial/update status of incoming events
Perform database entry for safety data
Code AEs and Products
Write narratives
Conduct literature-related activities as per internal/project timelines
Ensure compliance to all project-related processes and activities
Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs
Execute all required training in a timely fashion and document it
Create, maintain, and track cases as applicable to the project plan
Identify quality problems and bring them to the attention of a senior team member
Liaise with different functional team members (e.g., project management, clinical, data management) and healthcare professionals (e.g., investigators, medical monitors, site coordinators) to address project-related issues
Liaise with clients regarding day-to-day case processing activities
Mentor new team members, if assigned by the Manager
Attend project team meetings and provide feedback to the operations manager on any challenges/issues or successes
Perform other duties as assigned
Lead/Support department Initiatives
Review AE coding, past medical history, concomitant medications, expectedness/listedness, causality assessment, and other medical information
Ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines
Communicate with team leads for any corrections required in the case and maintain appropriate documentation for all communications
Distribute reports and data to internal and external stakeholders

Skills

Key technologies and capabilities for this role

PharmacovigilanceSafety Data ProcessingAdverse Event CollectionDatabase EntryAE CodingProduct CodingNarrative WritingLiterature ReviewSOP ComplianceRegulatory ComplianceCase TrackingProblem SolvingStakeholder Liaison

Questions & Answers

Common questions about this position

What is the salary or compensation for the Operation Specialist role?

This information is not specified in the job description.

Is this Operation Specialist position remote or does it require office work?

This information is not specified in the job description.

What key skills are required for the Operation Specialist position?

Key skills include processing safety data per regulations and SOPs, performing pharmacovigilance activities like AE coding and narrative writing, medical review of non-serious AEs/ADRs, problem-solving, and liaising with team members and stakeholders.

What is the work environment or team structure like at IQVIA for this role?

The role involves working under the guidance of senior operation team members, liaising with functional teams like project management and clinical, mentoring new team members if assigned, and attending project team meetings.

What makes a strong candidate for the Operation Specialist role?

Strong candidates should have experience in pharmacovigilance, safety data processing, medical review of AEs/ADRs, attention to compliance with regulations and SOPs, problem-solving skills, and the ability to liaise with teams and stakeholders.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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