Job Overview:
Assist with the overall Clinical Safety and/or departmental operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Ensure that for assigned projects, expeditable adverse events reporting is completed to the required standard and submitted to client and regulatory agencies (if required) within the agreed/stated timelines. It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
Summary of Responsibilities:
- Oversee the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.
- Ensure compliant safety reporting in accordance with international reporting regulations, SOPs, and safety processing guidelines, for assigned projects.
- Maintain a strong understanding of Fortrea ’s safety database conventions or client-specific database conventions, as appropriate.
- Supports preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports,
- Development Safety Update Report (DSUR) Periodic Safety Reports (PSRs) line listings, and aggregate reports.
- Actively participate in and demonstrate leadership on projects which enhance team and/or division performance. This will include acting as safety lead for projects at global or regional level, ensuring communication and process harmonization.
- Work with internal or external partners for reconciliation of safety databases, if appropriate.
- May support workflow monitoring for assigned studies/programs to ensure deadlines are met.
- Draft/modify and deliver safety presentations as required, to external and internal stakeholders.
- Maintains a comprehensive understanding of Fortrea departmental Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting, and pharmacovigilance.
- Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact department.
- Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.
- Ensure compliant safety reporting in accordance with US and international regulatory reporting requirements, SOPs and safety processing guidelines set forth by departmental management team and the client.
- Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided.
- Build and maintain good departmental relationships across functional units.
- Engage in preparation of Safety Management Plans (SMPs), Reconciliation Plans and other safety specific plans under supervision.
- Engage in preparation of study specific job aids, instructions, trainings, and templates.
- Support systems set up during study start up and ongoing maintenance.
- Engage in taking decisions regarding adverse event reporting within the guidelines of each assigned project.
- Assist departmental management/safety leads with project financial management and identifying out of scope work.
- Engage in project specific functional management for assigned projects (access requests, training assignment etc.).
- Assist in TMF management activities as required.
- Actively participate in project team and client meetings and liaise with clients, where appropriate.
- Prepare and/or participate in internal, client or regulatory audits, and support other functional safety leads in audit preparation.
- Assist with the provision of data to Safety Committees/DSMBs.
- Demonstrate role-specific competencies on a consistent basis.
- Demonstrate company values on a consistent basis.
- And all other duties as needed or assigned.
Qualifications (Minimum Required):
- Non-degree + 5 years Safety experience*
- Associate’s degree + 3-4 years Safety experience*
- BS/BA + 3 years Safety experience*
- MS/MA + 2-3 years Safety experience* or 2 years relevant experience**
- PharmD + 1 year Safety experience* or 2 years relevant experience**
- For PharmD, a one-year residency of fellowship can be considered relevant experience.
- *Safety experience includes actual operational experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
- **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Project Management or Quality Assurance.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Language Skills Required:- Speaking: English and local language.
- Writing/Reading: English and local language.
Experience (Minimum Required):
- Strong verbal, written and presentation skills.
- Good communication and organizational skills.
- 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 inform supervisor, support in taking 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 Medical Device reporting desirable.
- Knowledge of worldwide regulatory requirements and reporting of adverse event for investigational products.
- Thorough knowledge and understanding of industry and R and D processes and objectives.
- Strong skills using MS office required.
Preferred Qualifications Include:
- Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry
Physical Demands/Work Environment:
- Office Environment.
Travel Requirement:- Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location
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