Specialist II, 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:

• Take ownership of assigned aspects of quality reviews on projects.
• Compile metrics and identify quality trends.
• Assist in addressing periodic client quality reviews and other ad-hoc client quality findings.
• Prepare initial drafts of Corrective and preventive actions.
• 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.
• Take ownership of assigned CAPAs with respect to ensuring that the actions are closed and produce documentary evidence to that effect in coordination with the project managers.
• Contribute to process reviews, own certain aspects of the reviews and use the results to help identify process improvements and develop process standards.
• Contribute to designing and tracking training schedule and training material for new hires and existing team.
• Help initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects.
• Assist in coordinating respective client or external audits of the assigned projects.
• Draft sections of the 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.
• Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables.
• 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.
• 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):

• Three years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least One year of 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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