Manager – Drug Safety Operations

About Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy. Working at Immuneel promises the excitement of an agile start-up on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are: Passionate in driving patient outcomes: We are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else. Responsible and accountable: We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance. Transparent, honest, and supportive in how we work together: We insist on integrity and respect for the individual. We demand excellence. Our performance management is focused on excellence through timely and constructive feed-forward. Inclusive and flexible: We are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. “Being and thinking different” is valued. Immuneel’s employees are integral to our quest to develop and deliver high quality engineered cell therapies in India. We believe that our culture provides an environment for employees to excel and find purpose. The strength of our team is every bit as important as our cutting-edge technology and we invest in clear compensation and comprehensive benefits for our employees. People for us, are not resources, but our capital. If you are a talented professional, an out-of-box thinker with a zeal to help change, and passionate about healthcare, we invite you to join us and be a part of a historic initiative in India. Interested to be a part of the next revolution in cancer treatment? Send your resume to 1. Role Title: Manager – Drug Safety Operations (Pharmacovigilance) 2. Department / Function: Clinical Development & Operations 3. Reporting Structure: Reports to: Clinical Development & Operations Direct Reports: Individual Contributor 4. Role Summary: The role reports to the Head – Clinical Development & Operations and works closely with the Medical Affairs, Clinical Operations, Regulatory Affairs, Quality, and other cross-functional teams. The role is responsible for the effective execution and oversight of pharmacovigilance and drug safety activities across clinical development and post-marketing settings. 5.

Key Responsibilities
Pharmacovigilance & Drug Safety Operations Manage day-to-day pharmacovigilance and drug safety activities across clinical development and post-marketing settings. Coordinate the collection, review, documentation, assessment, follow-up, and reporting of adverse events, serious adverse events, and other safety information. Ensure timely and accurate processing and reporting of individual case safety reports (ICSRs), as applicable. Safety Data Collection from Hospitals & Sites Establish and maintain effective processes for systematic collection of safety and relevant clinical outcome data from hospitals and healthcare institutions administering the organization's products. Coordinate with hospital teams, treating physicians, investigators and other healthcare professionals to ensure timely reporting of safety information. Develop and maintain mechanisms for ongoing follow-up of patients and collection of relevant safety and outcome information following product administration. Ensure timely identification and follow-up of missing, incomplete, inconsistent, or clinically important safety information. Coordinate reconciliation of safety information received from hospitals with internal safety databases, clinical databases, and other relevant data sources. Post-Marketing Surveillance & Real-World Data Generation Support the planning and execution of post-marketing surveillance (PMS) studies, safety monitoring programs, and real-world evidence (RWE) related data generation initiatives. Coordinate with Medical Affairs, Clinical Operations, hospitals, investigators, external partners, and other stakeholders for execution of PMS and RWE activities. Support development of study protocols, safety monitoring plans, data-collection tools, analysis plans, and related documentation. Vendor & External Stakeholder Management Manag