Job Description
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 & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.
Summary of Responsibilities:
• Responsible for instituting and implementing a Quality process across designated PV and safety writing engagements.
• Accountable for quality, CAPA and compliance related deliverables for the assigned PV and Safety writing engagements.
• Drive implementation of best practices and process improvement for the assigned projects.
• Responsible for driving quality culture for the assigned projects.
• Drive CAPA management and audit readiness across projects.
• Identify quality trends and suggest corrective actions.
• Implement a feedback process and track implementation of feedback.
• Function as a Point of Contact for the delivery team for regulatory updates, quality assurance concepts, applicable procedures, practices, and conventions on the assigned projects.
• Act as the process and quality expert for the Client.
• Initiate and support initiatives for standardization of quality processes and process excellence across projects within the practice.
• 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.
Responsible for Driving Proactive Quality processes across the project.
• Oversee all aspects of quality reviews, metrics, analysis, outcomes, actions across the projects.
• Support internal audits of PV/ Safety writing projects as per the audit calendar and support as required for general systems and process audits.
• Oversee and conduct process reviews to ensure regulatory and client requirements and implement process improvements.
• Work with delivery head & SME to develop, implement Quality Management Plan, provide inputs to Quality Agreements, Training Plans, and monitor Quality SLAs for all designated projects.
• Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests.
• Ensure implementation of Quality Management Plan and/or the Quality Agreement for assigned projects.
• Support Computer System Validation related activities as required.
• Perform a critical role to ensure organization wide inspection readiness at all times.
• Develop general or client-specific PV SOPs and WIs.
• Assess client conventions and provide inputs on their relevance to regulatory requirements.
• Assist delivery teams to identify training needs based on quality review findings.
• Identify process improvements and support delivery teams in the implementation.
• Support practice head in developing process framework, new offerings, and customized solutions for clients.
• Assist practice head in ensuring that training material & training plans are reviewed and updated on an ongoing basis, and in conducting training sessions.
• Support business development at practice level by contributing to RFP responses, proposals, and client presentations.
• 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):
• 10 years of experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with experience in Quality, leading quality, and process improvements across several Safety projects.
• Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines.
• In-depth understanding of single case processing, assessment, and safety writing.
• Understanding of Lean and Six sigma methodologies.
• Technical proficiency with Microsoft Office suite of applications.
• Understanding of system validations.
Preferred Qualifications Include: • Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective; experience in trending, identification of gaps & training needs is preferred.
Physical Demands / Work Environment:
• Office Environment
• Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.
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