Job Responsibilities:
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.
Location: Kolkata office based (Prefer candidate local to Kolkata).
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
•Graduates in Bpharm/ Mpharm/ PharmD (Freshers only).
• 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
• Good working knowledge of Microsoft Office and web-based applications. Beginner
• Strong organizational skills and time management skills. Beginner
• 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, 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
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
Kolkata, West Bengal, India
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