Safety & PV Specialist

As a Safety & PV Specialist I-Japanese at Syneos Health in Pune Office, your primary responsibility will be to ensure accurate and timely processing of Individual Case Safety Reports (ICSRs) in compliance with Standard Operating Procedures (SOPs) and regulatory requirements. You will play a crucial role in maintaining safety tracking, performing data entry into safety databases, coding events and medical history, and compiling narrative summaries. Additionally, you will be involved in the validation and submission of xEVMPD product records, management of duplicate ICSRs, and activities related to SPOR / IDMP. Your role will also include conducting literature screening and review for safety, maintaining drug dictionaries, and ensuring compliance with global drug regulations, Good Clinical Practice (GCP), and ICH guidelines. You will collaborate with internal and external stakeholders to generate expedited safety reports, participate in audits, and apply regulatory intelligence to safety reporting activities. At Syneos Health, we are committed to fostering a culture of diversity and inclusion where every individual feels valued and respected. You will have the opportunity to develop your skills through career advancement opportunities, supportive management, and comprehensive training programs. Join us in our mission to accelerate the delivery of therapies and make a difference in the lives of patients worldwide. To excel in this role, you should have a strong attention to detail, the ability to work effectively in a team environment, and a commitment to maintaining high standards of quality and compliance. Your contributions will be instrumental in supporting clinical trials and post-marketing programs, ensuring the safety and well-being of patients and enhancing the overall success of our organization. If you are passionate about making a meaningful impact in the field of biopharmaceutical solutions and are eager to collaborate with like-minded professionals, we invite you to explore the exciting opportunities available at Syneos Health. Join us in our mission to transform lives and drive innovation in healthcare. For more information about Syneos Health and our global impact, please visit our website at http://www.syneoshealth.com.,