Job
Description
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent thats bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force . We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below. Responsibilities: Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Monitor and download ICSRs from Eudravigilance (EV) for valid ICSRs Processing literature, spontaneous as well as clinical trial and solicited cases Schedule and perform search of literature reports for valid ICSR in PubMed and MLM Responsible for generation of reports and submission to health authority and business partners Ensure data entry of serious and non-serious ICSRs (Spontaneous, Solicited and literature) in ARGUS as per client SOP and WI with high level of data accuracy Responsible for coding events, indications and patient history based on MEDDRA Coding of suspect products as well as concomitant., Amending the narrative when required, Performing Labeling of events Responsible to obtain follow-up information for all serious and non-serious cases as per the guideline on Good Pharmacovigilance Practices (EU-GVP). Perform the submission of the processed cases to regulatory authority and report distribution to Partner. Communicate and interact effectively within and across all client key stakeholders and within internal team management as appropriate Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines Track and perform daily and monthly reconciliation of ICSRs as per client requirements EDUCATION: M.Pharm/Pharm D/Life sciences degree EXPERIENCE: A minimum of 1 year pharmacovigilance case processing experience or its equivalent. EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
