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 Req - 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. Req - Good knowledge of medical terminology. Intermediate - Working knowledge of applicable Safety Database. Beginner - Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner - Excellent attention to detail and accuracy. Beginner - Strong organizational skills and time management skills. Beginner - Solid 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, manage competing priorities and deadlines. Beginner - Ability to delegate to less experienced team members. Beginner - Willingness and aptitude to learn new skills across Safety service lines. Beginner - Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Beginner - Ability to work as a Team Player, contribute and work towards achieving Team goals. Beginner - Ensure quality of deliverables according to the agreed terms. Beginner - Demonstration of IQVIA core values while doing daily tasks Beginner - Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Beginner - Regular sitting for extended periods of time. Beginner - May require occasional travel. Beginner - Flexibility to operate in shifts. Beginner
📌 Safety Associate (Kolkata)
🏢 Iqvia
📍 Kolkata