Job Summary: 

• Process serious and non-serious adverse events into LAM and review of AE case in the Argus database
• Submit expedited reports to FDA
• Maintain a worldwide Adverse Event and safety database log and coordinate distribution of safety data
• Maintain the US Adverse Event and safety database and coordinate distribution of safety data
• Interact with data intake and entry group to ensure complete and quality output and provide guidance on follow-up
• Regularly review the literature to identify adverse event reports for data entry and submission
• Compile and review annual periodic reports and quarterly reports
• Perform reconciliation with business partners and vendors for AE report exchanges
• Handle product complaints related to adverse events
• Review signal detection of products monthly

Skills on Resume:

• Adverse Event Processing (Hard Skills)
• Argus Database (Hard Skills)
• FDA Reporting (Hard Skills)
• Safety Data Coordination (Hard Skills)
• Quality Assurance (Soft Skills)
• Literature Review (Hard Skills)
• Report Review (Hard Skills)
• Signal Detection (Hard Skills) 

Job Summary: 

• Take responsibility for vendor management of third-party Pharmacovigilance vendors
• Represent the Drug Safety Department internally and externally
• Set up new safety projects, including the development of Safety Management Plans
• Provide sponsor oversight of SAE processing by an outsourced vendor
• Cross-functional collaboration to maintain high quality of SAE reporting
• Contribute to evaluation, analysis, and presentation of safety data in respective documents and collaboration with independent expert boards.
• Ensure compliance with SOPs, GCP, and relevant regulatory environment of activities and documentation.
• Maintain knowledge of adverse event reporting processes and safety systems
• Contribute to the development, implementation, improvement, and standardization of new processes and methods.
• Participate in and support internal/external inspections and audits.

Skills on Resume:

• Vendor Management (Soft Skills)
• Department Representation (Soft Skills)
• Safety Project Setup (Hard Skills)
• Sponsor Oversight (Soft Skills)
• Cross-functional Collaboration (Soft Skills)
• Safety Data Evaluation (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Process Improvement (Soft Skills) 

Job Summary: 

• Ensure the company complies with adverse events regulatory requirements
• Help understand, monitor, and manage any adverse events related to the use of products
• Provide guidance and support to other teams and external parties
• Improve the safety reporting process and find new ways to raise standards.
• Ensure the company meets its responsibilities to provide a world-class vigilance system
• Responsible for case-processing activities
• Act as a Drug Safety specialist for certain products and therapeutic areas
• Use databases and online tools to ensure the provision of services
• Have a high attention to detail and a focus on quality
• Maintain an up-to-date knowledge of scientific information and therapeutic content 

Skills on Resume:

• Regulatory Compliance (Hard Skills)
• Adverse Event Management (Hard Skills)
• Team Guidance (Soft Skills)
• Process Improvement (Soft Skills)
• Vigilance System Management (Hard Skills)
• Case Processing (Hard Skills)
• Drug Safety Expertise (Hard Skills)
• Scientific Knowledge (Hard Skills) 

Job Summary: 

• Serve as the second line of contact for incoming calls to the medical affairs department
• Intake new and follow-up spontaneous Adverse Events and record the discussion in the relevant AE worksheet
• Writing case narratives for serious/non-serious, study reports, and quality/product complaint reports before sign-off by medical information specialist
• Evaluate cases for seriousness and expectedness criteria
• Enter AE cases in the safety database on time for further processing by MIS and Pharmacovigilance Group.
• Maintain Adverse event and safety database log and coordinate distribution of safety data
• Maintain verification of reconciliation and email correspondence in the Drug Safety shared drive
• Distribute adverse event reports to plant QA/GPV/partner companies following Safety Data Exchange Agreements (SDEAs)
• Obtain follow-up information via mail or telephone from healthcare professionals and consumers as per the relevant SOP or as per the ongoing medical conditions.
• Monitor the status of follow-up letters to ensure follow-up information is requested in the required timeframes
• Follow up with reporter/patient/HCP at defined intervals either
• Maintain US Adverse Event and safety database and coordinate distribution of safety data.

Skills on Resume:

• Call Management (Soft Skills)
• Adverse Event Intake (Hard Skills)
• Case Narrative Writing (Hard Skills)
• Case Evaluation (Hard Skills)
• Safety Database Management (Hard Skills)
• Data Coordination (Hard Skills)
• Report Distribution (Hard Skills)
• Follow-up Management (Soft Skills) 

Job Summary: 

• Interact with data intake and entry group to ensure complete quality and output and provide guidance on follow-up
• Handle Product Complaints related to Adverse Events.
• Perform reconciliation with business partners and vendors for AE reports exchanges
• Responsible for making appropriate decisions by applying knowledge of FDA ICH GCP and GVP standard regulations to write overall case summaries.
• Assist with Pharmacovigilance reconciliation of databases and listings (post-marketing and clinical trial sources)
• Assist with additional drug safety activities
• Perform retrospective equality review and document findings, and contribute to metric compilation
• Support the identification of corrections and creation of updates in the safety database following medical review.
• Implement and execute QC on key fields for serious cases.
• Offer during reviews and audits of safety data and database.
• Perform Individual Case Safety Report (ICSR) processing activities within the safety database and do quality checks on the assigned ICSR.
• Support for Regulatory Inspections.
• Distinguish and analyze the ratio of risk and benefits of the drug that is marketed.

Skills on Resume:

• Data Quality Assurance (Soft Skills)
• Product Complaint Handling (Hard Skills)
• AE Report Reconciliation (Hard Skills)
• Regulatory Knowledge Application (Hard Skills)
• Pharmacovigilance Reconciliation (Hard Skills)
• Quality Control (Hard Skills)
• Safety Data Review (Hard Skills)
• Risk-Benefit Analysis (Hard Skills) 

Job Summary: 

• Retrieve and process cases during normal hours of operation.
• Perform duplicate searches and book-in cases.
• Encode adverse events (AEs), (co)suspect product(s), and concomitant products following the company’s procedures.
• Select the appropriate as-reported causality and company causality (company causality will be assessed for all events in all cases).
• Assess the label/listed against the relevant labeling for the product.
• Assess the case as serious not labeled (SNL), serious labeled (SL), non-serious not labeled (NSNL), or non-serious labeled (NSLL).
• Create case narrative using the auto-narrative function in Argus, making minimal edits for clarity and medical orientation.
• Perform random QC of cases for awareness date, country of incidence, patient identifiers, company suspects product to capture and coding, event-capture, coding, seriousness, narrative, case-level causality, and the listed.
• Route the case to the appropriate workflow state in the safety database per company procedures.
• Promptly follow up on ICSRs per client procedures or when requested by the client.

Skills on Resume:

• Case Processing (Hard Skills)
• Duplicate Search (Hard Skills)
• Adverse Event Encoding (Hard Skills)
• Causality Assessment (Hard Skills)
• Labeling Assessment (Hard Skills)
• Case Narrative Creation (Hard Skills)
• Quality Control (Hard Skills)
• Case Routing (Hard Skills)