Job Summary:
Fortrea, a global leader in clinical research and drug development services, is hiring a Functional Quality Specialist II for its Pune location. This on-site role focuses on maintaining high-quality standards in pharmacovigilance, clinical safety processes, and regulatory documentation. If you have a passion for clinical quality operations and an eye for detail, this opportunity is ideal for enhancing your pharmaceutical career in a challenging and rewarding environment.
Key Responsibilities:
Manage assigned quality reviews across projects ensuring compliance and accuracy.
Compile and interpret metrics to identify quality trends and improvement areas.
Draft initial Corrective and Preventive Actions (CAPAs) and ensure timely closure.
Conduct comprehensive reviews of safety reports, labeling documents, and regulatory submissions such as PSURs, PADERs, IND reports, etc.
Review expeditable adverse events, product quality complaints, and medical information reports for global regulatory submissions.
Support client quality reviews, address findings, and assist with audits and inspections.
Contribute to process reviews, identify process improvements, and help develop process standards.
Design and track training schedules and materials for new and existing staff.
Analyze quality error trends and initiate process improvements across projects.
Provide guidance to safety associates handling telephonic or digital intake of adverse event data.
Coordinate Quality Management Plan drafting and other documentation for assigned projects.
Support regulatory inspections by preparing required documentation and coordinating with project teams.
Perform data analysis and suggest process excellence strategies.
Required Skills & Qualifications:
Experience in pharmacovigilance, clinical trials, or drug safety operations.
Strong understanding of global regulatory requirements (e.g., PSURs, PADERs, IND reports).
Excellent written and verbal communication skills.
Ability to perform data analysis and propose process improvements.
Familiarity with CAPA drafting and closure processes.
Proficient in safety database management and case processing.
Detail-oriented with strong organizational and planning skills.
Knowledge of safety data intake procedures across multiple channels (email, fax, phone).
Perks & Benefits:
Competitive salary package (Not specified in the description).
Comprehensive training programs for career development.
Opportunities for advancement within global clinical research projects.
Exposure to international regulatory standards and procedures.
Collaborative and growth-oriented work environment.
About Fortrea:
Fortrea is a globally recognized clinical research organization specializing in drug development and clinical trials. With a focus on innovation, quality, and regulatory compliance, Fortrea partners with top pharmaceutical and biotech companies to bring life-changing therapies to market.
Work Mode:
On-site (Pune, India)
Call to Action:
Ready to contribute to world-class clinical quality operations? Apply now to join Fortrea as a Functional Quality Specialist II and elevate your career in the pharmaceutical industry.
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