Team Lead/ Assistant Manager - Pharmacovigilance Technology

Soterius, Inc.; Dadri; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Soterius, Inc. in Noida is seeking a pharmacovigilance professional with 4-6 years of experience to implement and manage safety databases, oversee data migration, and configure data gateways.

The role includes IT compliance support, stakeholder communication, and end-to-end lifecycle support for PV projects. You will work across audits, SOP development, and training, contributing to quality and regulatory alignment while coordinating with CSV, QA, and cross-functional teams to deliver technology

Responsibilities

• Safety database implementation and management.
• Development and/or review of data migration mapping documents, scripts and execution of migration.
• Migration of data to and from safety databases such as Aris Global, Argus, etc.
• Configuration of Gateways for data interchange
• Supporting the IT Compliance activities within Soterius
• Communicate with required stakeholders, as necessary, to carry out the operational responsibilities.
• 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.
• Support in the management of various stages of the product development lifecycle, including requirements gathering, development, testing, validation, deployment, operations and retirement.
• Utilize core pharmacovigilance knowledge and experience for effective implementation, functioning and improvement of Soterius' technology solutions.
• Support effective functioning of PV projects (including but not limited to case processing, Literature Monitoring, Aggregate Reporting, Medical Writing, Signal Detection and Management, Medical Information and Risk Management etc.) in compliance with 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 PV projects.
• Train and mentor personnel, as needed.
• Respond to/ represent department/ function during audits and inspections.
• Author and review SOPs and other documents relevant for department/ function.
• Providing desired support related to computer system validations during audits & inspection done by customers and regulatory agencies.
• Coordinate with various stakeholders in the development and deployment process for Soterius' technology solutions, including developers, IT experts, CSV teams, QA teams and cross-functional client teams.
• Line management for assigned personnel.
• Identify new training and development requirements relevant to the function.
• Other responsibilities as assigned by the Management.

Job description

4-6 years

Noida

Full-Time

Key Responsibilities:

• Safety database implementation and management.
• Development and/or review of data migration mapping documents, scripts and execution of migration.
• Migration of data to and from safety databases such as Aris Global, Argus, etc.
• Configuration of Gateways for data interchange
• Supporting the IT Compliance activities within Soterius
• Communicate with required stakeholders, as necessary, to carry out the operational responsibilities.
• 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.
• Support in the management of various stages of the product development lifecycle, including requirements gathering, development, testing, validation, deployment, operations and retirement.
• Utilize core pharmacovigilance knowledge and experience for effective implementation, functioning and improvement of Soterius' technology solutions.
• Support effective functioning of PV projects (including but not limited to case processing, Literature Monitoring, Aggregate Reporting, Medical Writing, Signal Detection and Management, Medical Information and Risk Management etc.) in compliance with 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 PV projects.
• Train and mentor personnel, as needed.
• Respond to/ represent department/ function during audits and inspections.
• Author and review SOPs and other documents relevant for department/ function.
• Providing desired support related to computer system validations during audits & inspection done by customers and regulatory agencies.
• Coordinate with various stakeholders in the development and deployment process for Soterius' technology solutions, including developers, IT experts, CSV teams, QA teams and cross-functional client teams.
• Line management for assigned personnel.
• Identify new training and development requirements relevant to the function.
• Other responsibilities as assigned by the Management.