Sitero

Operations

• Operations Lead, PV works collaboratively with Global PV staff, and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance.
• Perform translations and/or quality review of the translations (manual / automated) of the incoming information (safety / non-safety).
• Perform accurate, complete, and timely translation of safety-relevant information.
• Perform end-to-end case processing and literature surveillance.
• Ensure compliance with international and local guidelines (like GDPR & and applicable data protection laws).
• Support in preparation of submission packages (local forms in local languages) for local Health Authority case submissions.
• Keep abreast of national pharmacovigilance and regulatory affairs regulations.
• Receive and handle medical information enquiries from patients and health care professionals.

Operations Lead, PV

• Local PV Officer works collaboratively with Global PV staff, and cross-functional colleagues/teams for pharmacovigilance activities.
• Ensure regulatory compliance according to applicable regional and national laws.
• Perform translations and/or quality review of incoming safety/non-safety information.
• Conduct non-English follow-ups for gathering safety information.
• Support in preparation of submission packages for local Health Authority case submissions.
• Keep abreast of national pharmacovigilance and regulatory affairs regulations.
• Receive and handle medical information enquiries from patients and health care professionals.

Manager, PV Operations

• Operations Lead, PV works collaboratively with Global PV staff, and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance according to the applicable regional and national laws for all medicinal product(s) and territory(ies) for Sitero is responsible.
• Perform translations and/or quality review of the translations (manual / automated) of the incoming information (safety / non-safety).
• Perform accurate, complete, and timely translation of safety-relevant information
• Perform end-to-end case processing and literature surveillance
• Ensure compliance with international and local guidelines (like GDPR & and applicable data protection laws) into account.
• Should have access to the reports of suspected adverse reactions and assist in monitoring the regulatory submissions.
• Perform non-English follow-ups via phone, email etc.
• Support in preparation of submission packages (local forms in local languages) for local Health Authority case submissions.
• Keep abreast of national pharmacovigilance and regulatory affairs regulations.
• Receive and handle medical information enquiries from patients and health care professionals.
• Must be contactable during business hours.
• Demonstrate knowledge and ensure compliance with current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), Sitero SOPs and quality standards.
• Stay current with international pharmacovigilance requirements and guidelines.
• Foster an environment of collaboration, team building, and continuous improvement.

Machine Learning Engineer

• Lead the development of next-generation AI technologies that power clinical trial platforms.
• Build scalable data pipelines for AI.
• Optimize model performance on hardware accelerators.
• Deploy state-of-the-art LLMs and Multi-Modal models.
• Collaborate with clinical operations, product, and research teams to translate complex business requirements into robust engineering solutions.
• Mentor engineers across the organization, fostering best practices in distributed systems, ML engineering, and the adoption of AI-native development workflows.

Software Engineer, Machine Learning

Full-stack Engineer

• Lead technical direction on high-impact projects, designing and maintaining large-scale software solutions that extend across the full stack - from data storage to UI design.
• Drive the design and implementation of state-of-the-art AI solutions and ML infrastructure, ensuring efficient model deployment, evaluation, and fine-tuning within our production environments.
• Serve as a technical leader in the design of scalable data loading and storage solutions, collaborating with research and infrastructure teams to support AI workloads.
• Pioneer the adoption of AI-native development workflows. You will actively use and integrate LLMs to generate boilerplate, refactor legacy code, write comprehensive tests, and optimize development velocity, setting the standard for the wider engineering team.
• Establish alignment and clarity across teams on goals and outcomes while influencing and coaching a distributed team of engineers.
• Apply in-depth knowledge of how AI infrastructure interacts with other systems to maximize training and inference performance, including optimizing hardware accelerators where necessary.

Software Engineer

• Own end-to-end clinical trial pharmacovigilance activities for Sponsor studies; serve as the operational backbone of the safety function
• Provide active Sponsor oversight of CRO pharmacovigilance activities, including compliance, quality, and performance metrics
• Lead or contribute to DSURs, IND Annual Reports, safety narratives, and line listings
• Aggregate, review, and analyze safety data across studies to identify trends and emerging safety signals
• Prepare integrated safety summaries and materials for safety review meetings and signal detection discussions
• Maintain continuous inspection readiness for FDA and global health authority inspections
• Coordinate literature surveillance, collaborate with biostatistics, and support cross-functional safety evaluations
• Liaise with Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management, and CRO partners

Drug Safety Operations Lead – Contract

DevOps Engineer

• Assist with the day-to-day operations of the IT Support team
• Support with any tickets related to Azure or AWS Cloud and deployment of applications
• Provide hands-on support for device and configuration issues
• Own and prioritize employee support tickets
• Develop and maintain a customer-centric support culture
• Maintain an updated IT knowledge base
• Collaborate with system administrators to assist with user system migrations
• Continuously evaluate and improve the support process
• Monitor and analyze IT Support metrics and performance indicators
• Provide coaching, mentoring, and training to users
• Liaise with other IT teams and departments

Operations Lead, PV

Manager, PV Operations

Operations Lead, PV

Software Engineer, Machine Learning

Software Engineer

Drug Safety Operations Lead – Contract

Cloud and IT DevOps Engineer