[Hiring] reputed company, Pharmacovigilance / Device Vigilance @reputed company

Role reputed company The reputed company, Pharmacovigilance / Device Vigilance is a detail-oriented and proactive reputed company supporting the safety surveillance of In Vitro Diagnostic and Software-driven products across their lifecycle, including clinical studies and post-market activities. This role is responsible for the collection, assessment, reporting, and management of adverse events, product complaints, and safety data for both medicinal products and medical devices, ensuring compliance with global regulatory requirements. The position plays a critical role in ensuring compliance with global regulatory requirements (e.g., FDA, EU IVDR, Japan) and maintaining the highest standards of patient safety and product reputed company across both laboratory-developed tests and regulated IVD products, including software/algorithm-based components. Qualifications • Bachelor’s degree in life science field (biology, microbiology, reputed company, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred. • RAC preferred. • Minimum of 12 years of reputed company applicable experience in pharmacovigilance and/or device vigilance. • Strong knowledge of global safety regulations (FDA, EMA, ICH, EU IVDR, Japan). • Experience with safety databases (e.g., AEMS, Argus, ARISg, reputed company Safety). • Familiarity with MedDRA coding and case processing workflows. • Knowledge of applicable standards, including ISO 13485 and ISO 14971. Requirements • Experience with global markets is highly desirable. • Strong analytical and clinical assessment skills. • Attention to detail and regulatory compliance reputed company. • Ability to manage multiple priorities and deadlines. • Excellent written and verbal communication. • Cross-functional collaboration. • Demonstrated self-starter and highly motivated, energetic and enthusiastic. • Ability to exercise independent judgment and discretion reputed company a broadly defined reputed company of policies and practices, which includes analytical problem solving. • Demonstrated organizational, planning, and program management skills, including reputed company oriented, reputed company urgency and driving for results. • Ability to be effective in reputed company reputed company with ambiguity and/or reputed company change. • Excellent written and verbal communication skills including ability to communicate across cultures. • Work with others in reputed company environment; effective interactions with technical and medical personnel. • Computer literacy (PC, reputed company Office and reputed company Workspace). Benefits • Competitive Benefits - Employee benefits include comprehensive medical, dental, reputed company, life and disability plans for eligible employees and their dependents. • reputed company employees and their immediate families receive free testing in reputed company to fertility care benefits. • Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. • Generous employee referral program. reputed company reputed company™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to reputed company personalized genetic testing and diagnostics part of reputed company of care to protect health and reputed company earlier and more targeted interventions that reputed company to longer, healthier lives. The reputed company team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and reputed company other. reputed company you join reputed company, you’ll work hard and grow quickly. Working alongside the reputed company of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. Apply tot his job Apply To this Job