Assistant Manager - Literature

Soterius, Inc.; Dadri; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Soterius, Inc. is seeking a literature monitoring lead to support pharmacovigilance operations in India. You will coordinate daily activities, ensure timely, accurate literature screening, and maintain compliance across SOPs and client requirements.

Key duties include guiding the team, training and coaching, managing workload, and preparing documentation for audits and regulatory inspections, with strong emphasis on quality and stakeholder communication.

Qualifications

• Strong experience in Pharmacovigilance, with relevant experience in Literature Monitoring.
• Experience in coordinating or supervising a team, with the ability to provide guidance, coaching, and day-to-day support to team members.
• Good knowledge of Pharmacovigilance regulations, guidelines, SOPs, and quality requirements.

Responsibilities

• Coordinate and support the day-to-day activities of the Literature Monitoring team, including workload allocation, task prioritization, and resource coordination.
• Provide guidance and coaching to team members to support consistent, accurate, and timely execution of Literature Monitoring activities.
• Review and support literature screening, abstract and full-text assessment to ensure adherence to applicable regulations, guidelines, SOPs, quality standards, and client requirements.
• Manage assigned projects and deliverables, ensuring activities are completed within agreed timelines and quality expectations.
• Monitor team productivity, quality metrics, workload, and KPIs, and escalate potential risks, quality issues, or resource concerns to management.
• Ensure appropriate documentation and compliance are maintained across Literature Monitoring activities.
• Support communication with internal and external stakeholders and participate in client meetings and project reviews as required.
• Identify team training and development needs and support the delivery of training, coaching, and knowledge-sharing activities.
• Support the function during audits and regulatory inspections by providing relevant documentation and information as required.
• Contribute to the preparation, review, and maintenance of SOPs, work instructions, and other relevant documents.
• Support continuous improvement initiatives, process enhancements, and quality improvement activities within the Literature Monitoring function.
• Perform other responsibilities as assigned by Management.

Skills

Pharmacovigilance

Team supervision

Regulatory compliance

Communication

Organizational skills

Job description

Responsible for supporting the day-to-day management of the Literature Monitoring function, including team coordination, project delivery, quality, compliance, and client requirements. The role will provide guidance and support to the team, monitor workload and deliverables, and help ensure timely, accurate, and compliant execution of literature monitoring activities.

Key Responsibilities:

• Coordinate and support the day-to-day activities of the Literature Monitoring team, including workload allocation, task prioritization, and resource coordination.
• Provide guidance and coaching to team members to support consistent, accurate, and timely execution of Literature Monitoring activities.
• Review and support literature screening, abstract and full-text assessment to ensure adherence to applicable regulations, guidelines, SOPs, quality standards, and client requirements.
• Manage assigned projects and deliverables, ensuring activities are completed within agreed timelines and quality expectations.
• Monitor team productivity, quality metrics, workload, and KPIs, and escalate potential risks, quality issues, or resource concerns to management.
• Ensure appropriate documentation and compliance are maintained across Literature Monitoring activities.
• Support communication with internal and external stakeholders and participate in client meetings and project reviews as required.
• Identify team training and development needs and support the delivery of training, coaching, and knowledge-sharing activities.
• Support the function during audits and regulatory inspections by providing relevant documentation and information as required.
• Contribute to the preparation, review, and maintenance of SOPs, work instructions, and other relevant documents.
• Support continuous improvement initiatives, process enhancements, and quality improvement activities within the Literature Monitoring function.
• Perform other responsibilities as assigned by Management.

Key Requirements:

• Strong experience in Pharmacovigilance, with relevant experience in Literature Monitoring.
• Experience in coordinating or supervising a team, with the ability to provide guidance, coaching, and day-to-day support to team members.
• Good knowledge of Pharmacovigilance regulations, guidelines, SOPs, and quality requirements.
• Strong communication, organizational, and stakeholder-management skills.
• Ability to manage multiple activities, priorities, and deadlines effectively.
• Strong attention to detail and commitment to quality and compliance.
• Experience in supporting audits, client interactions, training activities, and SOP/document management is preferred.
• Ability to identify issues, assess priorities, and appropriately escalating risks or concerns to management.