Job Description

Summary The Pharmacovigilance and Regulatory Specialist will be responsible for Pharmacovigilance activities and patient safety case-handling process, including regulatory reporting for ICSRs (Individual Case Safety Report) to ensure post-market compliance. Driving the development and strengthening of relationship with the Regulatory Authorities and consistent and quality regulatory practices and procedures which are in line with the rest of the National RA requirements and meet the needs of Central RA function. Approximately 75% PV related activities, 25% Regulatory related activities. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Roles and Responsibilities In all activities, to work closely with a team of PV and RA experts with a focus on India & South Asia Manage the entire documentation process related to reporting of Adverse Events with GE HealthCare products (as per local and global SOPs) Manage the local regulatory activities including support to Central RA(CRA) for product registration & license renewals and support to local commercial on operational issues (tender documentation & promotional material, etc.) Ensure that local RA activities reflect and support both local commercial and global business priorities. Act as an interface between Sales team & Global PV team in fulfilling local Pharmacovigilance related responsibilities (including training of local teams) Ensure post-market compliance. A key responsibility is to drive the development and strengthening of relationship with the Regulatory Authorities. May assist with global pharmacovigilance activities to support data safety and support quality of review documents Check for accuracy & completeness of information entered in the AE forms & follow-up with the stakeholders for missing information. Regular telephonic / email follow-up with Sales Team for all Adverse event related information requested by Global PV team Coordinate with QA team regarding product quality complaints with an AE Prepare and maintain a Monthly log of all PV related communications Provide support during any audit (Internal/Regulatory Agency) Ensuring that the national pharmacovigilance is compliant with national laws keeping up to date on local regulatory/legislation changes Required Qualifications This role requires 6+ plus advanced experience in the Quality & Product Surveillance. Knowledge level is comparable to a Bachelor\'s degree from an accredited university or college ( or a high school diploma with relevant experience) Graduate in scientific or related discipline Past experience in any pharmaceutical company / CRO in a Pharmacovigilance related role is desirable Desired Characteristics Advanced skills in using Internet, Microsoft Office/Excel/PowerPoint and safety database (Argus experience preferred) Good communication skills and fluent in English Proficiency in undertaking administrative tasks Self-motivated with ability to multi-task with ability to prioritize, schedule and organize daily activities Basic knowledge and understanding of the healthcare industry and the regulatory requirements for submissions of product registrations Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust lead with transparency deliver with focus, and drive ownership - always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you\'d expect from an organization with global strength and scale, and you\'ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-GM2

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