Operations Specialist 1 at IQVIA

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

< 30 days notice period and experience in LSMV / ArisG Database
Bachelor's Degree in Scientific or healthcare discipline or allied life sciences (Req)
Bachelors degree and up to 3 years experience or the equivalent combination of experience, training and education (Req)
Good knowledge of medical terminology (Intermediate)
Working knowledge of applicable Safety Database and any other internal/Client applications (Intermediate)
Knowledge of applicable global, regional, local clinical research regulatory requirements (Intermediate)
Excellent attention to detail and accuracy (Intermediate)
Maintain high quality standards (Intermediate)
Good working knowledge of Microsoft Office and web-based applications (Intermediate)
Strong organizational skills and time management skills (Intermediate)
Strong verbal/written communication skills (Intermediate)
Self-motivated and flexible (Intermediate)
Ability to follow instructions/guidelines, utilize initiative and work independently (Intermediate)

Responsibilities

Prioritize and complete the assigned trainings on time
Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements
Perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information, determining initial/update status of incoming events, database entry, coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines
Ensure to meet quality standards per project requirements
Ensure to meet productivity and delivery standards per project requirements
Ensure compliance to all project related processes and activities
Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required; ensure all required training is executed in a timely fashion and documented; work towards ensuring individual training plan and training transcript are reconcilable
Creating, maintaining and tracking cases as applicable to the project plan
Identify quality problems, if any, and bring them to the attention of a senior team member
Demonstrate problem solving capabilities
Liaise with different functional team members (e.g. project management, clinical, data management) and health care professionals (e.g. investigators, medical monitors, site coordinators and designees) to address project related issues
May liaise with client in relation to details on day to day case processing activities
Mentor new team members, if assigned by the Manager
Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes
Perform other duties as assigned
Lead/Support department Initiatives
100% compliance towards all people practices and processes
Depending on the project requirement, perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of 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 the team leads for any correction required in the case and maintain appropriate documentation for all communications

Skills

Pharmacovigilance

Safety Data Processing

Adverse Events

AE Coding

Database Entry

ArisG Database

LSMV

SOP Compliance

Case Management

Narrative Writing

Literature Review

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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