Safety Associate, Hybrid

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 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.

• 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.

• 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.

• 100% compliance towards all people practices and processes

• Perform other duties as assigned.

Qualifications

• High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences

• An understanding of the US FDA and international regulatory requirements for single case expedited reporting.

• An Individual with a minimum of a Bachelor’s Degree in scientific or healthcare discipline or allied life sciences graduation with 1-1.5 years of relevant experience.

• Good knowledge of medical terminology.

• Working knowledge of applicable Safety Database.

• Knowledge of applicable global, regional, local clinical research regulatory requirements.

• Excellent attention to detail and accuracy. Beginner

• Good working knowledge of Microsoft Office and web-based applications.

• Strong organizational skills and time management skills.

• Strong verbal/written communication skills.

• Self-motivated and flexible.

• Ability to follow instructions/guidelines, utilize initiative and work independently.

• Ability to multi-task, manage competing priorities and deadlines.

• Ability to delegate to less experienced team members.

• Willingness and aptitude to learn new skills across Safety service lines.

• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients.

• Ability to work as a Team Player, contribute and work towards achieving Team goals.

• Ensure quality of deliverables according to the agreed terms.

• Demonstration of IQVIA core values while doing daily tasks

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $53,900.00 - $89,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Salary : $53,900 - $89,800