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, HealthcareIndustries

Requirements

May perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs)
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, guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines
Communicate with team leads for corrections required in cases and maintain documentation for communications

Responsibilities

Review, assess, and process safety data and information received from various sources
Distribute reports and data to internal and external parties
Ensure compliance with regulations, SOPs, and internal guidelines under guidance of senior team members
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 cases
Code AEs and products, write narratives, and conduct literature-related activities per timelines
Ensure compliance with all project-related processes and activities
Read and acknowledge IQVIA SOPs and customer SOPs; execute and document required training timely
Create, maintain, and track cases per project plan
Identify quality problems and escalate to senior team member
Demonstrate problem-solving capabilities
Liaise with functional team members (e.g., project management, clinical, data management) and healthcare professionals (e.g., investigators, medical monitors, site coordinators)
Liaise with client on day-to-day case processing activities
Mentor new team members if assigned by Manager
Attend project team meetings and provide feedback to operations manager on challenges/issues or successes
Perform other duties as assigned
Lead/support department initiatives
Maintain 100% compliance with all people practices and processes

Skills

Key technologies and capabilities for this role

PharmacovigilanceAdverse EventsSafety Data ProcessingDatabase EntryAE CodingNarrative WritingSOP ComplianceCase TrackingLiterature ReviewProblem Solving

Questions & Answers

Common questions about this position

What is the salary for the Operation Specialist role?

This information is not specified in the job description.

Is this a remote position or what is the location requirement?

This information is not specified in the job description.

What skills are required for this Operation Specialist position?

Key skills include processing safety data per regulations and SOPs, performing pharmacovigilance activities like AE coding and narrative writing, ensuring compliance with processes, demonstrating problem-solving, and liaising with team members and healthcare professionals.

What is the company culture or team environment like at IQVIA for this role?

This information is not specified in the job description.

What makes a strong candidate for the Operation Specialist position?

Strong candidates should have experience in pharmacovigilance activities such as processing safety data, AE coding, narrative writing, ensuring regulatory compliance, problem-solving, and the ability to liaise with teams and mentor new members.

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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