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):
• 15 +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 ofsystem 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.
Learn more about our EEO & Accommodations request here.
Skills Required
- Bachelor’s, master’s, or PhD degree in medicine, alternative medicine, medical science, pharmaceutical science, nursing, life sciences, or a related field; equivalent relevant experience may be considered.
- 15 or more years of experience in the pharmaceutical, biotechnology, or CRO industry.
- Primary experience in pharmacovigilance or safety writing, quality leadership, and process improvement across multiple safety projects.
- Knowledge of good pharmacovigilance practices and applicable European Union 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 applications.
- Understanding of computer system validation.
- Experience assessing the quality of case or safety reports from medical, scientific, and documentation perspectives.
- Experience with quality trending, gap identification, and training-needs analysis.
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
