SENIOR DRUG SAFETY ASSOCIATE – CLINICAL SAFETY & PHARMACOVIGILANCE
Location: Noida, India
Employment Type: Full-Time
Experience Required: 2 – 4 Years
Department: Clinical Safety & Pharmacovigilance
POSITION 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 Reports
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 & Compliance Management
Perform end-to-end ICSR case processing activities.
Ensure adherence to:
Client agreements
Regulatory requirements
Pharmacovigilance guidelines
Internal procedures
Monitor timelines and quality metrics for assigned projects.
Escalate compliance concerns and operational risks when necessary.
Technology & Systems Support
Support implementation and maintenance 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.
Project Ownership & Stakeholder Management
Take ownership of assigned projects and deliverables.
Ensure timely completion of assigned tasks while maintaining quality standards.
Coordinate and communicate with internal and external stakeholders.
Support project execution and operational effectiveness.
Quality & Documentation Management
Ensure quality, compliance, and documentation standards are maintained across assigned projects.
Maintain accurate records and project documentation.
Support quality management initiatives and continuous improvement activities.
Training & Mentorship
Train and mentor junior team members as required.
Identify departmental training needs.
Support skill development and knowledge-sharing initiatives.
Audit & Inspection Support
Participate in internal and external audits and inspections.
Represent the department during client, regulatory, and quality audits.
Support audit preparation and response activities.
Ensure readiness for regulatory inspections.
SOP & Process Documentation
Author, review, and update:
Standard Operating Procedures (SOPs)
Work Instructions
Departmental Documentation
Compliance Documents
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
Signal Detection Concepts
Safety Surveillance Activities
Familiarity with post-marketing and clinical trial safety reporting requirements.
Uttar Pradesh :
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