Safety & PV Specialist

Role Overview: 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. Key Responsibilities: - Ensure accurate and timely processing of Individual Case Safety Reports (ICSRs) in compliance with SOPs and regulatory requirements. - Maintain safety tracking, perform data entry into safety databases, code events and medical history, and compile narrative summaries. - Validate and submit xEVMPD product records, manage duplicate ICSRs, and perform activities related to SPOR / IDMP. - Conduct literature screening and review for safety, maintain drug dictionaries, and ensure compliance with global drug regulations, Good Clinical Practice (GCP), and ICH guidelines. - Collaborate with internal and external stakeholders to generate expedited safety reports, participate in audits, and apply regulatory intelligence to safety reporting activities. Qualifications Required: - Strong attention to detail. - Ability to work effectively in a team environment. - Commitment to maintaining high standards of quality and compliance. Note: Syneos Health is committed to fostering a culture of diversity and inclusion where every individual feels valued and respected. They provide career advancement opportunities, supportive management, and comprehensive training programs to help employees develop their skills. If you are passionate about making a meaningful impact in the field of biopharmaceutical solutions and are eager to collaborate with like-minded professionals, explore the exciting opportunities available at Syneos Health to transform lives and drive innovation in healthcare. For more information about Syneos Health and their global impact, visit their website at http://www.syneoshealth.com.,