Operations Specialist 1

IQVIA LLC; Ernakulam; On-site; INR 450,000 - 750,000; Full time

Job summary

IQVIA LLC is seeking an Biomedical Safety Data Reviewer to process safety information and support pharmacovigilance across project requirements. You will enter data, code events, write narratives and ensure quality standards are met while complying with SOPs.

The role involves collaboration with project teams and mentoring newer members in a fast-paced environment. Based in India, you will contribute to data integrity and timely reporting, while maintaining training plans and professional growth

Qualifications

• Bachelor's Degree in Scientific or healthcare discipline required.
• Experience up to 3 years or the equivalent combination of experience, training and education.
• Good knowledge of medical terminology.
• Working knowledge of applicable Safety Database and client applications.
• Knowledge of global, regional, local clinical research regulatory requirements.
• Excellent attention to detail and accuracy.
• Maintain high quality standards in documentation and processes.
• Good working knowledge of Microsoft Office and web-based applications.
• Strong organizational and time management skills.
• Strong verbal/written communication skills.
• Self-motivated and flexible, able to work independently.
• Ability to multi-task, meet deadlines and manage priorities.
• Willingness to learn across Safety service lines.
• Ability to communicate effectively with coworkers, managers and clients.
• Team player contributing to team goals.

Responsibilities

• Prioritize and complete the assigned trainings on time.
• Process Safety data according to applicable regulations, SOPs and project requirements.
• Perform Pharmacovigilance activities including collecting and tracking adverse events data.
• Determine initial/update status of incoming events and perform data entry.
• Code AE and products, write narratives and literature-related activities.
• Ensure to meet quality and productivity standards per project requirements.
• Ensure compliance to all project related processes and activities.
• Read and acknowledge IQVIA SOPs and customer SOPs as required.
• Execute training plans and maintain training transcripts.
• Mentor new team members when assigned by the Manager.
• Attend project team meetings and provide feedback on challenges and successes.
• Lead or support department initiatives and ensure 100% compliance with people practices.

Skills

Attention to detail

Time management

Communication skills

Team player

Problem solving

Education

Bachelor's Degree in Scientific or healthcare

3 years experience or equivalent

Tools

Safety Database

Client applications

Microsoft Office

Job description

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.

Essential Functions

• To Prioritize and complete the assigned trainings on time.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To 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.
• To 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 your 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.
• To demonstrate problem solving capabilities.
• Liaise with different functional team members, e.g. project management, clinical, data management
• 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.
• To mentor new teams 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

Qualifications

• Bachelor's Degree 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
• Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate
• Ability to delegate to less experienced team members. Intermediate
• Ability to be flexible and receptive to changing process demands. Intermediate
• Willingness and aptitude to learn new skills across Safety service lines. Intermediate
• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate
• Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate
• Ensure quality of deliverables according to the agreed terms. Intermediate
• Demonstration of IQVIA core values while doing daily tasks Advanced
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate
• Regular sitting for extended periods of time. Intermediate
• May require occasional travel. Intermediate
• Flexibility to operate in shifts. Intermediate

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.