Assistant Manager - Pharmacovigilance Technology
Crius Life Sciences · Noida · onsite · Posted 2d ago
Undisclosed5–7 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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.
This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Administrative SupportIT Complianceline managementAggregate Reportingmedical writingCase ProcessingArgusauditsCSVMappingdeploymentDatabase ImplementationDevelopment And DeploymentData MigrationLiteraturecompliance
About Crius Life Sciences
Crius Life Sciences
201
employees
₹4.1L PA avg
Avg at Crius Life Sciences
About
Soterius is a healthcare and life sciences services company specializing in pharmacovigilance, regulatory affairs, and clinical research support. It partners with pharmaceutical and biotech firms to ensure drug safety, compliance, and efficient development processes. By combining scientific expertise with technology-driven solutions, Soterius helps organizations meet global regulatory standards and deliver safe, effective therapies to patients.
Industries
Manufacturing
Employee ratings
10 reviews
4.3/ 5
Culture
3.5
Career growth
3.0
Work-life
3.9
Employees rate it well for
Overall Company43Work-Life Balance42
Find them on