SENIOR DRUG SAFETY ASSOCIATE – CLINICAL SAFETY & PHARMACOVIGILANCE
Location: Noida, India
Employment Type: Full-Time
Experience Required: 2–4 Years
Department: Clinical Safety & Pharmacovigilance
JOB OVERVIEW
The Senior Drug Safety Associate will support Clinical Safety and Pharmacovigilance operations by ensuring accurate and compliant processing of safety information, including adverse event reporting, case processing, project management, quality compliance, and stakeholder coordination. The role requires strong knowledge of pharmacovigilance regulations, safety databases, and clinical safety processes while maintaining high standards of quality and compliance.
KEY RESPONSIBILITIES
Drug Safety & Pharmacovigilance Operations
Support drug safety and pharmacovigilance activities as assigned by management.
Record, review, and process Adverse Drug Reactions (ADRs) in safety databases for post-marketing and clinical trial reports.
Ensure compliance with applicable regulatory requirements, client procedures, and internal quality standards.
Maintain high accuracy and quality in Individual Case Safety Report (ICSR) processing.
Case Processing & Project Management
Perform end-to-end ICSR case processing activities.
Ensure compliance with client agreements, regulatory requirements, and pharmacovigilance guidelines.
Manage assigned projects and tasks while ensuring adherence to timelines and quality standards.
Escalate compliance concerns, operational risks, or quality issues when necessary.
Technology & Systems Support
Support development and deployment of pharmacovigilance technology solutions.
Assist with:
System administration
Validation activities
Software upgrades
Bug fixes
Change requests
User support
Participate throughout the product and system lifecycle.
Quality & Compliance Management
Ensure quality, compliance, and documentation standards across assigned projects.
Maintain accurate records and project documentation.
Support quality assurance initiatives and continuous improvement activities.
Monitor compliance with applicable regulations and internal procedures.
Stakeholder Management
Collaborate with internal teams, clients, and external stakeholders.
Ensure effective communication regarding project status, compliance requirements, and operational activities.
Build strong working relationships to support project success.
Training & Development
Train and mentor junior team members as required.
Identify training needs and support skill development initiatives.
Participate in knowledge-sharing and continuous learning programs.
Audit & Inspection Support
Support internal and external audits and inspections.
Represent the department during client, quality, and regulatory audits when required.
Assist with audit preparation, documentation, and responses.
Documentation & SOP Management
Author, review, and update:
Standard Operating Procedures (SOPs)
Work Instructions
Departmental Documentation
Compliance Records
Ensure documentation aligns with regulatory and organizational requirements.
Administrative Responsibilities
Perform administrative duties related to assigned projects and departmental activities.
Support operational and compliance-related documentation.
Undertake additional responsibilities assigned by management.
REQUIRED KNOWLEDGE & TECHNICAL SKILLS
Pharmacovigilance Knowledge
Understanding of Pharmacovigilance principles and practices.
Knowledge of:
Adverse Event Reporting
ICSR Processing
Safety Surveillance Activities
Clinical Safety Reporting
Familiarity with post-marketing and clinical trial safety reporting requirements.
Regulatory Knowledge
Working knowledge of:
ICH Guidelines
Good Pharmacovigilance Practices (GVP)
FDA Regulations
EMA Regulations
Global Pharmacovigilance Requirements
Systems & Technology
Experience with safety databases such as:
Argus Safety
ARISg
Veeva Safety
Oracle Safety Systems
Other Pharmacovigilance Platforms
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