Description
We are seeking a Clinical Safety and PSS Operations Assistant to support our operations in São Paulo. The successful candidate will assist with the overall Clinical Safety and/or PSS operations associated with products, including the entire adverse events process.
Responsibilities:
- Manage the receipt and processing of all adverse event reports, including safety database entry, AE review, and writing patient narratives with coding.
- Manage submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, and other stakeholders within the required timelines.
- Ensure all cases that require expediting reporting to worldwide Regulatory Agencies or other recipients are prioritized for processing and submission within the regulatory and/or study-specific applicable timelines.
- Prepare timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), and Development Safety Update Reports (DSURs).
- Participate in signal detection, trend, and pattern recognition activities, as appropriate.
- Maintain a strong understanding of Labcorp's safety database conventions and client-specific database conventions, as appropriate.
- Work with Data Management or clients on reconciliation of safety databases, if necessary.
- Monitor workflow for assigned studies/programs to ensure all deadlines are met.
- Prepare and deliver safety presentations, as needed.
- Maintain a comprehensive understanding of Labcorp PSS Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents, and directives associated with safety management, reporting, and pharmacovigilance.
- Participate in the generation of monthly status and other project-specific reports, ensuring the quality and accuracy of metrics/data provided.
- Support and train less experienced safety staff in all aspects of case-handling, adverse event reporting, and other work, as needed.
Qualifications:
- Non-degree + 4 years of Safety experience or 5-6 years of relevant experience.
- Associate degree + 3 years of Safety experience or 4-5 years of relevant experience.
- BS/BA + 3 years of Safety experience or 3-4 years of relevant experience.
- MS/MA + 2 years of Safety experience or 3 years of relevant experience.
- Degree preferred in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
Experience:
- Good verbal, written, and presentation skills.
- Good communication skills.
- Ability to interact and influence with line and middle management, staff, and external contacts on a functional and tactical level.
- High degree of accuracy with attention to detail.
- Functions as a team player.
- Ability to present and share useful business information across departments and functions.
- Ability to anticipate and identify problems and take appropriate action to correct.
- Knowledge of medical and drug terminology.
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
- Knowledge of ICH Guidelines.
- Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.