Job Description

Job Overview:

Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the 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. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company's Health and Safety Manual.

Summary of Responsibilities:

Assume accountability of quality of the deliverables and implementation of quality processes with minimal support from the Manager. Function as a Point of Contact for the delivery team for regulatory updates, quality concepts, applicable procedures, practices, and conventions on the assigned projects. Act as the process and quality expert for the Client. Work with other team members to analyze Quality findings and help develop action plans. Ownership of responding to and addressing periodic client quality reviews and other ad-hoc client quality findings. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC's, Med Guides etc. Assist with the overall functional quality 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). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Provide adequate oversight to ongoing sample case reviews and perform reviews as required. Publish quality metrics based on this review and use it to ensure deliverables meet agreed quality targets. Identify, report quality trends to internal and external stakeholders, suggest corrective actions and monitor the execution and closure. Assume ownership of quality of reports and CAPAs as assigned. Ensure that CAPAs are implemented for the assigned project. Conduct process review in coordination with Project Manager and Quality Manager to identify process gaps and proactively coordinate with the delivery team to develop process standards and suggest process improvements. Measure and track audit readiness for assigned projects. Lead authoring, reviews, training and distribution of SOPs, project specific Work Instructions / convention documents etc. Work with individuals in identifying training needs based on quality review findings. Assist in designing sign-off criteria, development and tracking of training schedule and training material for new hires and existing team. Ensure that periodic feedback is provided to the team based on review findings. Initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects. Communicate with internal Subject Matter experts to get clarification on case-processing queries and providing feedback to team. Responsible to coordinate and handle queries during the client or external audits of the assigned projects. Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests. Responsible for developing Quality Management Plan and / or contributing to the Quality Agreement for assigned projects. Support Computer System Validation related activities as required. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes - a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned - tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. All other duties as needed or assigned.

Qualifications (Minimum Required):

Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

Five years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least Two years' experience in Peer review/Quality review. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Knowledge of Quality Assurance. Awareness of lean methodology concepts. Technical proficiency with Microsoft Office suite of applications.

Preferred Qualifications Include:

Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective is preferred.

Physical Demands/Work Environment:

Office Environment or remote. Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.

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