Support in the area of drug safety and pharmacovigilance activities as requested by the management.
Record and review adverse drug reactions in the safety database or other database, as relevant, for post marketing and clinical trial reports in accordance with the applicable regulatory standards and Soterius’ clients’ procedures, with high accuracy and quality.
Provide support in the development and deployment of the assigned technology solutions, including administrative support, implementation, validation, upgrades, bug fixes, change requests and support throughout the product lifecycle.
Communicate with required stakeholders, as necessary.
Carry out the necessary administrative duties required for the job.
Ensure effective functioning of assigned projects (including but not limited to ICSR case processing and compliance with client agreements and applicable regulations and guidelines.
Have ownership of assigned projects and tasks and ensure adherence to timelines and quality.
Management of quality, compliance, and documentation across assigned projects.
Alert the functional head /designate in the event of concerns or issues regarding personnel management that may affect the quality and functioning of the work.
Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulations, and guidance.
Train and mentor personnel, as needed.
Respond to /represent department /function during audits and inspections, as required.
Author and review SOPs and other documents relevant to department and function, as required.
Provide support in Soterius’ technology systems deployments, for external as well as internal systems. This will include hosted safety and medical information databases, internally developed technology solutions as well as all other GxP-relevant technology solutions.
Work on Configuration of technology systems.
Work on validation, release management, and documentation activities.
Providing desired support related to computer system validations during audits & inspection done by customers and regulatory agencies.
