SME-Pharmacovigilance Cognizant

About Cognizant

Cognizant is a multinational information technology services and consulting firm headquartered in the United States. Its headquarters are located in Teaneck, New Jersey, in the United States. Cognizant is listed on the NASDAQ-100 under the symbol CTSH.

Job Description

The role of SME-Pharmacovigilance is essential in upholding the safety and effectiveness of pharmaceutical products. As a candidate in this position, you will utilize your expertise in PV Case Processing and customer service to optimize pharmacovigilance operations. It is crucial to adopt a proactive approach to monitor drug safety and contribute to research and development endeavors. Your responsibilities will include triaging and intake of ICSRs in ARGUS databases within agreed timelines, monitoring and downloading valid ICSRs from sources like Eudra Vigilance (EV), processing various types of cases, conducting literature searches for valid ICSRs, and submitting reports to health authorities and business partners. Ensuring accuracy in entering serious and non-serious ICSRs in ARGUS, coding events and patient information using MedDRA, and obtaining follow-up information for all cases are vital aspects of the role. Additionally, you will be responsible for submitting processed cases to regulatory authorities, communicating effectively with stakeholders, attending trainings for compliance, and maintaining adherence to regulatory requirements and industry standards. To excel in this role, you are required to possess a Bachelor's or Master's degree in pharmacy, along with a minimum of 3 years of relevant work experience in case processing activities. Experience in specific therapeutic areas such as Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology, and Gene Therapy will be advantageous, especially if gained in a global pharma sponsor setting. A comprehensive understanding of global, regional, and local regulatory requirements, including GCP, GVP, and ICH guidelines and SOPs, is essential. Strong organizational and time management skills, proficiency in Microsoft Office and web-based applications, and knowledge of medical terminology are also necessary for this role. Furthermore, you will be involved in the development and maintenance of standard operating procedures, support training initiatives to enhance team capabilities, troubleshoot process-related issues, and provide consistent support across different time zones by engaging in rotational shifts. Your contribution to ensuring consistency, quality, and smooth operations in pharmacovigilance and safety processes will be integral to the success of the team and the organization.,