Senior Associate - Clinical Safety and Pharmacovigilance

Soterius, Inc.; Dadri; On-site; INR 600,000 - 1,100,000; Full time

Job summary

Soterius, Inc. is seeking a Senior Associate - Clinical Safety and Pharmacovigilance in Noida. This full-time role requires 2-4 years of experience and focuses on ensuring PV project effectiveness, compliance, and high-quality delivery.

The position involves coordinating with internal and external stakeholders, training staff, and participating in audits and SOP development. Based in Noida, this on-site role offers growth within a clinical safety environment.

Qualifications

• 2-4 years of experience in clinical safety and pharmacovigilance.
• Ability to work with cross-functional teams and stakeholders.
• Strong understanding of PV regulations and guidelines.

Responsibilities

• Ensures effective functioning of PV projects in compliance with client agreements and applicable regulations and guidelines.
• Has ownership of assigned projects and tasks and ensures adherence to timelines and quality.
• Manages quality, compliance, and documentation across PV projects.
• Alerts 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 works with internal and external stakeholders to ensure compliance with agreements, applicable regulations, and guidance.
• Trains and mentors personnel, as needed.
• Identifies new training and development requirements relevant to the function.
• Responds to and/or represents the department/function during audits and inspections.
• Authors and reviews SOPs and other documents relevant to the department/function, as assigned by Management.
• Manages and monitors the workload of the department/function and alerts the Functional Head/Designate regarding personnel management concerns or issues that may affect the quality and functioning of work, as assigned by Management.
• Performs line management responsibilities for assigned personnel, as assigned by Management.
• Carries out other responsibilities as assigned by Management.

Job description

Senior Associate - Clinical Safety and Pharmacovigilance

2 - 4 Years

Noida

Full-Time

Key Responsibilities:

• Ensures effective functioning of PV projects in compliance with client agreements and applicable regulations and guidelines.
• Has ownership of assigned projects and tasks and ensures adherence to timelines and quality.
• Manages quality, compliance, and documentation across PV projects.
• Alerts 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 works with internal and external stakeholders to ensure compliance with agreements, applicable regulations, and guidance.
• Trains and mentors personnel, as needed.
• Identifies new training and development requirements relevant to the function.
• Responds to and/or represents the department/function during audits and inspections.
• Authors and reviews SOPs and other documents relevant to the department/function, as assigned by Management.
• Manages and monitors the workload of the department/function and alerts the Functional Head/Designate regarding personnel management concerns or issues that may affect the quality and functioning of work, as assigned by Management.
• Performs line management responsibilities for assigned personnel, as assigned by Management.
• Carries out other responsibilities as assigned by Management.