Scientist Patient Safety
1800 Concord Pike Talleyville, DE 19803 US
Target Pay Rate: 30-38.73/hr **salary will be commensurate with experience
- Conducts activities and interactions consistent with organizational values and behaviors and in compliance with client's Code of Conduct and supporting policies and standards relevant to the role. Completes all required training on the Code of Conduct and supporting policies and standards within established timeframes. Reports potential issues of noncompliance.
- Conducts and/or supports a wide range of moderate to sometimes multifaceted scope and complex pharmacovigilance activities on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes and guidelines.
- Demonstrates a solid working knowledge of FDA regulations to allow for background understanding of organizational procedural documents (global and local) to ensure accurate local implementation of objectives, policies, procedures, regulatory requirements, and obligations relevant to pharmacovigilance activities and adverse event reporting, including periodic safety reporting.
- Provides oversight of the vendor responsible for handling the triage process and data entry for incoming documents to insure timely and effective medical and scientific evaluation of adverse event information.
- Provides oversight of the vendor responsible for handling of requesting followup information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes.
- Provides oversight of adverse event documents prepared by the vendor for accuracy, completeness, and validity prior to submission to the FDA.
- Provides oversight of the vendor responsible for handling the entry and maintenance of accurate tracking systems for all AE reports in appropriate pharmacovigilance databases.
- Provides oversight of the vendor responsible for handling of request and submitting literature articles.
- Responsible for the correction of errors that may be associated with the submission of expedited reports to the FDA.
- Provides oversight of the vendor responsible for handling and preparation of submissions of Investigational New Drug (IND) Suspected Unexpected Serious Adverse Reactions (SUSARs) to the FDA.
- Provides oversight of the vendor responsible for handling and preparation of the US Investigator Safety Letters (ISL) to the ISL Administration group for onward distribution to the US Investigators.
- Completes monthly reconciliation of Adverse Event (AE) data exchanged between US vendors and in association with US Licensing Agreements.
- Completes various standard quality checks of systems, processes, and other tasks.
- Manages the US Patient Safety mailboxes for AE reports and queries
- Bachelors degree in science / healthcare related field or proven Patient Safety experience equivalence in a similar role, and an excellent clinical background. Advanced degree is preferred.
- Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least two years of Patient Safety experience.
- Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse event reporting.
- Basic competence with medical and therapeutic terminology
- Able to work independently, guided by procedures, with appropriate support
- Able to work effectively as part of a team
- Demonstrable communication skills
- Maintains high ethical standards, including a commitment to client's values and behaviors
- Good attention to detail
- Good time management
- Fluent in English
- Computer literate
- Professional qualification
- Project Management experience
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.