8 Icsr Processing Jobs

As a Safety & PV Specialist I (Japanese Language Expert) at Syneos Health, you will play a crucial role in ensuring the safety of patients by handling and processing Individual Case Safety Reports (ICSRs) in compliance with regulatory requirements. Your responsibilities will include: - Entering information into PVG quality and tracking systems for ICSRs receipt and tracking - Assisting in processing ICSRs according to SOPs and safety plans - Triaging ICSRs, evaluating data for completeness and accuracy - Entering data into safety database, coding events, medical history, medications, and tests - Compiling complete narrative summaries and identifying information to be queried - Generating exp...

As a Safety & PV Trainee at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. By entering information into PVG quality and tracking systems, processing ICSRs, and maintaining safety tracking, you will contribute to the accurate and timely reporting of safety data. Your responsibilities will include: - Entering information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assisting in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. - Triaging ICSRs, evaluating ICSR data for complet...

Job description Business: Critical Care Department: Pharmacovigilance Location: Kurla, Mumbai Travel: No Reporting Structure Reports to Manager Essential Qualification Bachelors/ Masters degree in Pharmacy Experience Overall 2-3 years of experience in Pharmacovigilance with at least 1 year of relevant work experience in ICSR processing, Literature screening and authoring of aggregate safety reports like PADERs, PBRERs etc. Key Roles/Responsibilities End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines. Mai...

Role & responsibilities We are seeking a Pharmacovigilance Associate with 2 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in processing Individual Case Safety Reports (ICSRs) and performing literature screening to identify safety information. This includes assessing validity of literature abstracts/articles for database entry. The role also involves maintaining XEVMPD, performing EVWEB updates, revising SmPCs, PILs, and preparing Risk Management Plans (RMPs). Monitoring safety updates/signals and ensuring SOP & regulatory compliance is essential. Preferred candidate profile Eudravigilance, XEVMPD Maintenance, EVWEB Updates, SmPC ...

What you will do In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations Roles & Responsibilities: Monitor, solve, and resolve issues related to adverse event data processing across multiple...

In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations Roles & Responsibilities: Monitor, solve, and resolve issues related to adverse event data processing across multiple systems. Conduct...

Reporting Structure Reports to Manager Key Roles/Responsibilities End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines. Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of ICSRs. Enter and/ or submit cases to applicable regulatory authority safety databases. Perform and monitor literature for company molecules. Maintain and update safety logs and safety files. Prepare and share compliance data with QPPV. Provide data for compliance representation/monthly in...

What you will do In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations Roles & Responsibilities: Monitor, solve, and resolve issues related to adverse event data processing across multiple...