7 Safety Databases Jobs

Job Title: Patient Safety Regional Service Director (JPN) Career Level: F Introduction To Role Are you ready to make a significant impact on patient safety in Japan AstraZeneca is on a mission to improve the lives of 200 million patients by delivering 20 new medicines by 2030. As the Patient Safety Regional Service Director, you'll play a pivotal role in achieving this bold ambition. Join our Global Business Services (GBS) team, where we're enhancing customer focus and establishing Research & Development Services to drive AstraZeneca's vision forward. This role is your opportunity to lead and manage our GBS Patient Safety Hub in Japan, ensuring excellence in pharmacovigilance processes and c...

Role Overview: You will be the Global Head of Clinical Development & Patient Safety Solutions at Sandoz, ensuring that Clinical Development & Patient Safety stakeholders achieve their goals using technology systems. Your role involves working closely with stakeholders to understand their evolving needs, challenges, opportunities, and priorities. As a Stakeholder Success Lead, you will represent the face of Technology to the stakeholder community. Key Responsibilities: - Stakeholder Engagement: - Facilitate dialogues to address business issues through technology. - Align technology strategy with business needs. - Manage priorities for Clinical Development & Patient Safety. - Develop and maint...

As a Medical Information Associate at Fortrea, your primary responsibilities will include: - Responding to medical information queries, product quality complaints, and general queries in French over various communication channels such as telephone calls, emails, and faxes on a 24x7 shift basis. - Recording and reporting Adverse Drug Reactions promptly and in compliance with regulations and internal WI/SOPs. - Executing drug safety data management processes involving call intake, call dialogue documentation, peer review, and case follow-up. - Supporting various assigned activities including tracking information and metrics, quality control of process steps, training, and data reconciliation f...

Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and signal detection. Writing Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER), and Clinical Expert Statements., Publishing, distribution, archiving and submission of safety reports. Preparation of Signal detection reports, including EVDAS screening if applicable. Preparation of SARs (Signal Assessment Reports). Writing Risk Management Plans (RMPs). Identifying safety concerns and providing advice with regard to future ri...

As a PV Subject Matter Expert at ProPharma, your role involves providing oversight and direction to enhance client service both internally and externally. Your key responsibilities include: - Developing detailed project/program specific documents such as Working Practices and Work Instructions - Serving as a resource for the Case Processing team for complex cases and escalated inquiries - Performing case follow-up activities and creating/reviewing case narratives - Providing client notifications as required for case management - Contributing to the development of training materials and delivering training - Identifying areas of concern/discrepancies related to ICSRs - Acquiring and maintaini...

Summary Of Responsibilities Respond to medical information queries (In French)/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc. Execute drug safety data management processes a combination of call intake, call dialogue documentation, peer review, case follow-up. Perform and support different activities as assigned tracking several types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple so...

Summary Of Responsibilities Respond to medical information queries (In French)/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc. Execute drug safety data management processes a combination of call intake, call dialogue documentation, peer review, case follow-up. Perform and support different activities as assigned tracking several types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple so...