Specialist I, Process Compliance Review and Analysis

Job Overview:

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:

• Perform Quality review of assigned cases.
• Assist in compiling quality metrics based on this review and identifying quality trends.
• Assist in addressing periodic client quality reviews.
• Assist in preparation of Corrective and preventive actions as requested.
• Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers.
• 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.
• Assist in the conduct of process review for assigned process and measure and monitor audit readiness.
• Assist in designing and tracking training schedule and training material for new hires and existing team.
• Contribute to discussion forums on Quality errors within assigned project and help identify process improvements.
• Assist in coordinating respective client or external audits of the assigned projects as requested.
• Assist in development of Quality Management Plan for assigned project.
• Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / 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.
• 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.
• Contribute to process review and use results to identify the process improvement initiatives.
• Coordinate with the project team to support sponsor during the regulatory inspections or audits as applicable.
• Review of product quality complaints, medical/general information queries and respond back to reporter/consumer as per agreed procedures and captures this information in required formats agreed with Sponsor.
• Review of a sample of various safety reports for global regulatory submissions for Fortrea clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports, Investigator brochures and sections of protocols, Clinical Study Reports etc.
• 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, Biological Sciences, or related area.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Two plus years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with some experience in Peer review/Quality review.
• 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) and GVP requirements related to clinical safety and post marketing documentation.
• Knowledge of ICH Guidelines.
• Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.
• Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines.
• In-depth understanding of case processing and assessment.
• 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.
• Knowledge of Medical Device reporting desirable.

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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