Job Summary: 

• Complete case processing goals such as data entry, event extraction, triage, and selecting the necessary coding
• Execute a preliminary case assessment to determine the expectations of the case based on the medical context
• Confirm the case meets the necessary criteria for events of special interest
• Review ICSR information and source documents to ensure completeness, consistency, and accuracy.
• Execute QC on cases obtained by other members of the team
• Investigate missing case information and perform follow-up requests until their necessary completion. 
• Ensure the documentation of all queries
• Have knowledge of regulatory requirements and complete adverse event reports within the regulation of company SOPs, FDA, ICH, EMA, and SDEA time frames
• Help with the review and preparation of ICSRs, and safety summaries/reports
• Work collaboratively with external and internal partners, such as PV physicians
• Assist with the development of work instructions, forms, SOPs, conventions, or other internal documents.

Skills on Resume:

• Data Entry (Hard Skills)
• Event Extraction (Hard Skills)
• Medical Case Assessment (Hard Skills)
• Quality Control (Hard Skills)
• Investigative Research (Hard Skills)
• Regulatory Knowledge (Hard Skills)
• Collaborative Communication (Soft Skills)
• Document Preparation and Review (Hard Skills) 

Job Summary: 

• Electronically track all cases and source documents received to ensure information to be captured is not missed and the appropriate Day 0 is recorded
• Verify the following company Procedure Documents for the accuracy and completeness of all source documents received
• Ensure the minimum information is present for all cases as identified in company Procedure Documents
• For all ICSRs received, identify and query critical missing information to register the case (e.g. country of reporter or occurrence, missing clock start date, missing company product)
• Perform a duplicate check to determine if a report is duplicate, initial, or follow up to an existing report
• Complete case registration following the applicable company Procedure Document
• Register all cases in the Global Safety Database within 2 business days of receipt
• Confirm case receipt/acknowledgment (based on company SOPs and/or Process Documents) for digital and non-digital cases.
• Request additional information on cases followed up by the company if an assessment is deemed necessary for medical evaluation of the case outside of standard queries
• Assist with follow-up activities based on medical review queries following company Procedure Documents
• Perform follow-up for all applicable cases and document in the Global Safety Database following company Procedure Documents
• Monitor and review outstanding follow-up query action items for applicable cases within the Global Safety Database

Skills on Resume:

• Case Tracking (Hard Skills)
• Document Verification (Hard Skills)
• Information Querying (Hard Skills)
• Duplicate Checking (Hard Skills)
• Case Registration (Hard Skills)
• Global Safety Database Management (Hard Skills)
• Follow-up Coordination (Soft Skills)
• Process Monitoring (Hard Skills) 

Job Summary: 

• Effectively utilize available tools to perform assigned safety deliverables.
• Consult and collaborate with safety physicians and other appropriate personnel to effectively complete assigned safety deliverables.
• Communicate relevant safety information appropriately and on time.
• Author safety sections, perform analysis of safety data, and provide oversight of timelines and other contributing functional areas 
• Ensure completion of periodic reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs) and Risk Management Plans (RMPs).
• Complete safety data analysis and authoring of safety sections for ad-hoc safety reports and routine surveillance purposes.
• Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (QPPV) and ensure support is provided to fulfill the QPPV legal responsibilities.
• Adhere to requirements in quality system documents for assigned safety deliverables to ensure compliance with local laws and regulations.
• Understand and apply Global Patient Safety business practices
• Identify and act on internal process improvements in product safety standards and practices.

Skills on Resume:

• Tool Utilization (Hard Skills)
• Collaboration (Soft Skills)
• Safety Communication (Soft Skills)
• Safety Data Analysis (Hard Skills)
• Report Authoring (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Knowledge of Pharmacovigilance (Hard Skills)
• Process Improvement (Soft Skills)