Senior Drug Safety Associate

Soterius, Inc.; Dadri; On-site; INR 650,000 - 900,000; Full time

Job summary

Soterius, Inc. is seeking a Senior Associate – Clinical Safety and Pharmacovigilance to support drug safety activities and review adverse drug reactions in safety databases for post-marketing and clinical trials.

You will assist in developing and deploying technology solutions, manage ICSR processing, and collaborate with stakeholders to ensure compliance with applicable regulations and client agreements. Strong administrative skills and attention to quality are essential.

Responsibilities

• Record and review adverse drug reactions in safety databases for post-marketing and clinical trial reports per regulatory standards and client procedures.
• Provide support in development and deployment of technology solutions, including admin tasks, validation, upgrades and bug fixes.
• Communicate with required stakeholders as necessary.
• Carry out necessary administrative duties for the role.
• Ensure effective functioning of assigned projects including ICSR case processing and regulatory compliance.
• Take ownership of assigned projects and ensure timelines and quality.
• Manage quality, compliance, and documentation across projects.
• Alert the head or designate to personnel-management concerns that may affect work quality.
• Collaborate with internal and external stakeholders to ensure compliance with agreements and guidance.
• Train and mentor personnel as needed.
• Identify new training and development requirements relevant to the function.
• Respond to/represent department during audits and inspections.
• Author and review SOPs and other documents relevant to department and function.
• Perform other responsibilities as assigned by Management.

Job description

Job Overview: Senior Associate – Clinical Safety and Pharmacovigilance

Key Responsibilities-

• 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.
• Identify new training and development requirements relevant to the function.
• 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.
• Other responsibilities as assigned by the Management.