Soterius Senior Drug Safety Associate – Pharmacovigilance

Soterius Senior Drug Safety Associate Recruitment 2026

Soterius is hiring a Senior Drug Safety Associate for its Clinical Safety and Pharmacovigilance function in Noida.
The role is suitable for professionals with 2–4 years of experience in Drug Safety and Pharmacovigilance activities.
The position involves ICSR case processing, adverse event review, safety database activities, compliance, quality management, documentation, and client requirements.
The selected professional will also support technology solutions, audits and inspections, SOP development, training, and assigned Pharmacovigilance projects.

Senior Drug Safety Associate – Clinical Safety & Pharmacovigilance

Job Overview

The Senior Drug Safety Associate will support Clinical Safety and Pharmacovigilance activities as requested by management and will be responsible for assigned projects, tasks, quality, compliance, and documentation.

The role includes activities related to post-marketing and clinical trial safety reports, ICSR case processing, regulatory compliance, safety databases, technology solutions, and stakeholder coordination.

Job Role & Responsibilities

The Senior Drug Safety Associate will be responsible for:

• Support Drug Safety and Pharmacovigilance activities as requested by management.
• Record and review Adverse Drug Reactions (ADRs) in the safety database or other relevant databases.
• Process post-marketing and clinical trial reports in accordance with applicable regulatory standards and Soterius client procedures.
• Ensure high levels of accuracy and quality during safety case processing.
• Support the development and deployment of assigned technology solutions.
• Provide administrative support for technology solutions, including:

  • Implementation
  • Validation
  • Upgrades
  • Bug fixes
  • Change requests
  • Product lifecycle support

• Communicate with required stakeholders as necessary.
• Carry out administrative duties required for the role.
• Ensure effective functioning of assigned projects, including ICSR case processing.
• Ensure compliance with client agreements, applicable regulations, and guidelines.
• Take ownership of assigned projects and tasks.
• Ensure adherence to defined timelines and quality requirements.
• Manage quality, compliance, and documentation across assigned projects.
• Alert the functional head or designated person regarding concerns or issues relating to personnel management that may affect work quality and functioning.
• Work continuously with internal and external stakeholders to ensure compliance with agreements, regulations, and applicable guidance.
• Train and mentor personnel as required.
• Identify new training and development requirements relevant to the function.
• Respond to or represent the department/function during audits and inspections, as required.
• Author and review SOPs and other relevant departmental documents.
• Perform other responsibilities assigned by management.

Eligibility & Qualifications

Experience

2–4 years of experience

The supplied job description specifically focuses on experience in Clinical Safety and Pharmacovigilance, including ICSR case processing, safety database activities, quality, compliance, and regulatory requirements.

Educational Qualification

The supplied job description does not state a specific educational qualification.

For a Pharmacovigilance role of this nature, relevant Pharmacy, Life Sciences, or healthcare qualifications may be applicable, but the source does not specify a mandatory degree.

Eligible Qualification Courses

B.Pharm | M.Pharm | Pharm.D | B.Sc. Life Sciences | M.Sc. Life Sciences

The above course list is role-aligned; the supplied job description itself does not specify mandatory educational qualifications.

Pharmacovigilance & Drug Safety Skills

The role involves experience or exposure to:

• Clinical Safety
• Pharmacovigilance
• ICSR Case Processing
• Adverse Drug Reactions
• Safety Database Management
• Post-Marketing Safety Reports
• Clinical Trial Safety Reports
• Regulatory Compliance
• Client Procedures
• Quality Management
• Compliance Management
• Safety Documentation
• SOP Authoring and Review
• Audit and Inspection Support
• Training and Mentoring
• Pharmacovigilance Technology Solutions

Quality & Compliance Responsibilities

The position requires maintaining quality and compliance across assigned projects, including:

• Compliance with client agreements
• Applicable regulations and guidelines
• Quality requirements
• Documentation requirements
• Project timelines
• SOP compliance
• Audit and inspection readiness

Job Location & Details

Company: Soterius

Job Title: Senior Drug Safety Associate

Function: Clinical Safety and Pharmacovigilance

Location: Noida, Uttar Pradesh

Employment Type: Full Time

Experience: 2–4 years

How to Apply

Interested and eligible candidates can apply online through the official Soterius careers portal.

Apply Now – Soterius Senior Drug Safety Associate

Job Summary