- Project management
- Protection of participants’ safety and rights
- Site identification, evaluation and development
- Site monitoring, management and training
- Research operations
- Laboratory capacity building, auditing, and training
- Logistical support
- Author Safety Management Plan for assigned studies
- Configures and participates in validation of safety database systems
- Attend internal and client meetings as appropriate
- Attend and present at Investigator Meetings
- Identify, track, and file potential adverse event (AE) information.
- Actively participates in the case initiation process (case triage) and case data inputting/data entry as more complete SAE information becomes available.
- Responsible for monitoring all incoming information and identification of potential AE information and assembling data for team meetings
- Participates in the case narrative generation, review and refinement process depending upon level of experience.
- Conducts several rounds of query and response (back to site) under the guidance of Medical reviewers to gain complete and accurate case information.
- Navigates Safety Database including the advancing of cases within the workflow and understanding and conducting of various medical coding applications.
- Processes all field and narrative case data entry.
- Processes all Adverse Effects (AE), medical history and con meds coding.
- Ensures that all international regulations are followed regarding pharmacovigilance procedures.
- Perform quality control activities including the review of source documents and case data to verify accuracy and consistency as well as to ensure compliance with timelines and quality standards
- Participates as a cross functional team member of project team.
- Participates in Serious Adverse Event (SAE) Reconciliation activities with the SAE information in the clinical trial database.
- Performs periodic Global Safety Database searches to support inquiries from stakeholders as required.
- Prepare and submit periodic safety reports as needed. May assist in the creation of ad hoc safety reports for submission to relevant stakeholders both inside and external to FHI Clinical.
- Reviews all cases for completeness and accuracy of data versus available source documents.
- Ensures that in all received and created documentation, that patient privacy and confidentiality of identity be maintained and recommends steps that should be taken to avoid or mitigate breaches.
- Represent Safety Management on customer and project teams and in meetings.
- Monitor and report key performance indicators as appropriate.
- Authoring Standard Operating Procedures (SOPs) and Work Practice Instructions.
- All other duties as assigned.
- Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
- Good understanding of computer technology, and management of relational database systems, including extraction of data
- Demonstrated understanding of global pharmaceutical drug development and drug lifecycles.
- Direct experience reviewing and/or authoring standard operating procedures.
- Established client facing communication skills – ability to manage situations, negotiate conflicts, and influence others to achieve objectives
- Strong follow-up and organizational skills.
- Strong problem solving/process improvement skills with ability to be part of and own solutions.
- Drive to seek solutions with intent and priority through a balance of creativity and restraint.
- Expected and empowered to make decisions without direct supervision. Ability to work well independently and within a team.
- Handle confidential and sensitive matters with discretion.
- Statements regarding minimum educational and experience qualifications, required proficiencies with specialized knowledge, clinical experience/expertise, required certifications, computer proficiencies, etc.
- Preferred Job-related Experience: 2-3 years industry experience in Safety Management/Pharmacovigilance for a pharma, biotech, and/ or contract/academic research organization. Experience with drug safety databases, case processing and MedDRA coding concepts.
- Additional Eligibility Qualifications: Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint). Excellent oral and communication skills with technical writing experienced required.
- Standard office working environment
- Ability to sit and stand for extended periods of time, ability to lift 5-30 lbs.
- Expected travel time is up to 20% for this position.
Tags: FHI 360
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