Senior Drug Safety Associate – Clinical Safety & Pharmacovigilance
Company: Soterius
Location: Noida, India
Department: Clinical Safety & Pharmacovigilance
Employment Type: Full-Time
Role Summary
The Senior Drug Safety Associate is responsible for managing pharmacovigilance and drug safety activities across clinical trial and post-marketing programs. The role involves ICSR case processing, adverse event review, safety database management, regulatory compliance, project ownership, quality management, stakeholder communication, audit support, and SOP development while ensuring compliance with global pharmacovigilance regulations and client requirements.
Key Responsibilities
ICSR Case Processing & Safety Operations
Process and review Individual Case Safety Reports (ICSRs).
Record adverse drug reactions in safety databases.
Perform case assessment for:
Seriousness
Expectedness
Completeness
Regulatory compliance
Manage post-marketing and clinical trial safety reports.
Ensure high-quality case processing within timelines.
Pharmacovigilance & Drug Safety
Support global drug safety and pharmacovigilance activities.
Ensure compliance with:
GVP Guidelines
ICH Guidelines
Regulatory Authority Requirements
Client SOPs
Support safety surveillance and reporting activities.
Maintain safety documentation and compliance records.
Safety Systems & Technology Support
Support implementation and maintenance of safety technology solutions.
Assist with:
System Validation
Upgrades
Change Requests
Bug Fixes
Lifecycle Support
Provide administrative and operational support for safety systems.
Project Management
Own assigned PV projects and deliverables.
Ensure compliance with:
Client Agreements
Regulatory Requirements
Internal Quality Standards
Monitor project timelines and quality metrics.
Escalate risks and issues proactively.
Quality & Compliance
Ensure quality management across assigned projects.
Maintain audit-ready documentation.
Support regulatory inspections and client audits.
Participate in CAPA implementation and compliance activities.
Training & Mentoring
Train and mentor junior team members.
Identify training needs within the function.
Support capability development initiatives.
Share pharmacovigilance best practices.
Documentation & SOP Management
Author, review, and update:
SOPs
Work Instructions
Safety Documentation
Process Documents
Ensure compliance with company and regulatory requirements.
Stakeholder Management
Collaborate with:
Internal Teams
Clients
Regulatory Stakeholders
Project Teams
Provide timely communication and issue resolution.
Support cross-functional project execution.
Required Qualifications
Education
Bachelor's or Master's degree in:
Pharmacy
Life Sciences
Medical Sciences
Clinical Research
Biotechnology
Related Healthcare Discipline
Experience
2–4 years of experience in:
Pharmacovigilance
Drug Safety
ICSR Case Processing
Clinical Safety Operations
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