Senior Intake Operations Scientist - Hyderabad / Bangalore
About The Position
The Sr. Intake Operations Scientist is responsible for ensuring the timely, accurate, and compliant intake of adverse events, product quality complaints, and related safety information within the Global Safety System. This role provides operational oversight, vendor management, compliance monitoring, and process leadership to support Global Medical Safety objectives and regulatory requirements. The successful candidate will serve as a subject matter expert for intake processes, due diligence and follow-up activities, and related pharmacovigilance operations, driving operational excellence and continuous improvement initiatives. They will be comfortable working both independently and as part of cross-functional teams, building strong partnerships, influencing stakeholders, and delivering solutions that support compliance and business objectives.
Requirements
- Bachelor's degree in a scientific, healthcare, life sciences, or related discipline.
- Previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including individual and aggregate reports. Typically demonstrated by a minimum of 5+ years pharma experience
- Knowledge of global pharmacovigilance regulations and safety reporting requirements.
- Experience working in a high-volume operational environment with demonstrated ability to manage competing priorities.
- Strong analytical, problem-solving, and process improvement skills.
- Excellent written, verbal, and presentation skills.
- Experience working with safety databases, workflow systems, and Microsoft Office applications.
- Experience supporting regulatory inspections, audits, compliance investigations, and corrective and preventive action management.
- Experience overseeing external vendors and service provider performance.
- Experience with safety systems and technologies such as Local Safety Multi-Vigilance, literature surveillance platforms, or related pharmacovigilance systems.
- Demonstrated ability to lead cross-functional projects and drive operational improvements.
Nice To Haves
- Clinical Operations
- Coaching
- Critical Thinking
- Cross-Functional Collaboration
- Health Intelligence
- Performance Measurement
- Pharmacovigilance
- Process Optimization
- Quality Control (QC)
- Quality Management Systems (QMS)
- Regulatory Affairs Management
- Report Writing
- Root Cause Analysis (RCA)
- Safety Investigations
- Safety-Oriented
- Serious Adverse Event Reporting
- Technologically Savvy
Responsibilities
- Lead and oversee Case Receipt activities, including adverse event intake, due diligence/follow up requests, literature surveillance, complaint management, and business partner reconciliation processes.
- Provide operational oversight and support for external service providers and vendor partners, including performance monitoring and issue resolution.
- Serve as a subject matter expert and key point of contact for intake operations and due diligence/follow up requests, collaborating with Global Medical Safety, Product Quality Vigilance, Commercial, Legal, Regulatory, Technology, and regional safety organizations.
- Identify opportunities to improve efficiency, compliance, and effectiveness through process optimization, automation, data analysis, and system enhancements.
- Support regulatory inspections, audits, and health authority inquiries, including preparation, interview support, and response activities.
- Investigate compliance issues and support development, implementation, and effectiveness verification of Corrective and Preventive Actions.
- Lead or participate in cross-functional projects supporting process standardization, operational excellence, and implementation of technology solutions including SafetyVerse, EZ Reporter, and literature surveillance systems.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
