Job title: Lead Consultant – Reg. Affairs

Company: Genpact

Job description: With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world&rsquos biggest brands&mdashand we have fun doing it. Now, we&rsquore calling all you rule-breakers and risk-takers who see the world diffe

With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world&rsquos biggest brands&mdashand we have fun doing it. Now, we&rsquore calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us. Are you the one we are looking for We are inviting applications for the role of Lead Associate or Lead Consultant, Pharmacovigilance (PV) Regulatory affairs. In this role, you are responsible for identification of adverse events (AEs) and product quality complaints (PQCs), translation of relevant data into English, coding potential safety data to MedDRA terminology, sorting data into safety categories, expediting valid AE/PQC cases, and recording non-valid AE cases in an external Dashboard for client safety evaluation. Responsibilities: . A pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures specialises in drug safety management, clinical trials and medical supervision. . Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and avoiding adverse effects or side effects of marketed pharmaceutical products. . The role includes activities of important case report follow-up processing and writing adverse event programs serving link between the company, healthcare experts and patients for delivery of valid information on product safety . identification of adverse events (AEs) and product quality complaints (PQCs), translation of relevant data into English, coding potential safety data to MedDRA terminology, sorting data into safety categories, expediting valid AE/PQC cases to client, and recording non-valid AE cases in an external Dashboard for Client safety evaluation. . Following up with patients and healthcare providers to get the full clinical picture of possible adverse drug events . Categorization of PV data captured from social media sources valid AE, non-valid AE and product quality complaint (PQC), and will be recorded as follows: . Non-valid adverse events (AEs) captured in a customizable Dashboard . Reporting of Valid AEs and PQCs as per agreed timeline . Provide accurate and timely responses to medical information queries . Provide medical writing and literature surveillance for the client as per established process . Processing Individual Case Study Reports (ICSRs) from a variety of sources including literature reports, health authority reports (e.g.ASPRs) and spontaneous reports . Carrying out ICSR local reporting . Reviewing data entry of ICSRs onto a safety database and MeDRA coding . Providing guidance on PSMF (Pharmacovigilance Safety Master File) administrator activities and case processing, quality review of PADERs and line listing . Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels. . Demonstrated oral and written communication skills. . Demonstrated understanding of related fields . Ability to generate innovative solutions to problems and effectively collaborate with and communicate with key stakeholders. . Active participation in departmental improvement activities. . Demonstrate flexibility in responding to changing priorities, multi-tasking, and dealing with unexpected events. Qualifications we seek in you! Minimum Qualifications . Bachelor’s or master&rsquos degree required in science, or related field (advanced degree preferred) Preferred Qualifications . Effective leadership, communication, and interpersonal skills . Advanced knowledge of MS Office . Superior attentiveness to detail Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.

Expected salary:

Location: Mumbai, Maharashtra

Job date: Sun, 24 Apr 2022 22:36:42 GMT

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