Pharmacovigilance Reporting Specialist
Job Details
Company: ICON
Job Requisition ID: JR155584
Department: Pharmacovigilance / Drug Safety
Locations: Chennai, Trivandrum, Bangalore, India; Mexico City, Mexico
Work Model: Office or Home
Employment Type: Full-time
Job Posted: Recently
Company Overview
ICON is a global healthcare intelligence and clinical research organization focused on accelerating the development of new medicines and treatments.
The organization emphasizes:
Integrity
Collaboration
Agility
Inclusion
Patient-focused research
Quality and compliance
Role Overview
The Pharmacovigilance Reporting Specialist will support pharmacovigilance and drug safety activities with primary responsibility for the preparation, analysis, and submission of safety reports.
The role requires strong knowledge of pharmacovigilance processes, regulatory requirements, safety data analysis, and reporting standards. The successful candidate will work collaboratively with cross-functional teams to ensure that pharmacovigilance deliverables are accurate, complete, compliant, and submitted within required timelines.
Key Responsibilities
Pharmacovigilance Reporting
Prepare comprehensive pharmacovigilance safety reports.
Prepare and support submission of Periodic Safety Update Reports (PSURs).
Prepare and manage Individual Case Safety Reports (ICSRs).
Ensure reports comply with applicable regulatory requirements and internal procedures.
Maintain accuracy, completeness, consistency, and quality of safety information.
Ensure pharmacovigilance deliverables are completed within agreed timelines.
Safety Data Analysis
Conduct detailed analysis of pharmacovigilance and drug safety data.
Identify trends and emerging safety patterns.
Assess safety information associated with pharmaceutical products.
Review available safety data to support appropriate pharmacovigilance conclusions.
Ensure safety information is accurately interpreted and presented in required reports.
Adverse Event Reporting
Collaborate with relevant teams to ensure timely reporting of adverse events.
Review safety information associated with adverse event reports.
Support appropriate processing and reporting of safety cases.
Ensure adverse event information is handled according to applicable procedures and regulatory requirements.
Regulatory Compliance
Maintain current knowledge of pharmacovigilance regulations.
Monitor relevant regulatory expectations and industry best practices.
Apply regulatory requirements to pharmacovigilance reporting activities.
Ensure all assigned deliverables meet internal quality standards and regulatory expectations.
Maintain a strong focus on compliance and inspection readiness.
Cross-Functional Collaboration
Work closely with internal and external stakeholders to support pharmacovigilance activities, including:
Pharmacovigilance teams
Drug Safety teams
Clinical teams
Regulatory Affairs
Medical teams
Quality teams
Clients
Other relevant stakeholders
Coordinate activities to ensure accurate and timely completion of safety reporting requirements.
Training and Knowledge Support
Provide training and guidance to team members on pharmacovigilance reporting processes.
Support team members in understanding reporting requirements and procedures.
Share relevant regulatory and process updates.
Contribute to continuous improvement of pharmacovigilance reporting practices.
Quality Management
Maintain high standards of accuracy and quality across pharmacovigilance activities.
Review deliverables for completeness, consistency, and compliance.
Identify potential quality issues and ensure appropriate resolution.
Follow applicable internal procedures, regulatory requirements, and client-specific requirements.
Required Qualifications
Bachelor's degree in:
Life Sciences
Pharmacy
Healthcare-related disciplines
Other relevant scientific fields
Required Experience
Significant experience in pharmacovigilance reporting or drug safety.
Experience within a:
Pharmaceutical company
Clinical research organization
Healthcare environment
Practical experience with pharmacovigilance reporting activities.
Experience preparing or supporting safety reports is highly relevant.
Technical Skills
Strong understanding or experience in:
Pharmacovigilance
Drug Safety
PSURs
ICSRs
Adverse Event Reporting
Safety Data Analysis
Regulatory Reporting
Pharmacovigilance Compliance
Safety Reporting Processes
Reporting Software
Data Analysis Tools
Analytical Skills
The candidate should demonstrate:
Strong analytical ability.
Ability to identify trends in safety data.
Ability to interpret pharmacovigilance information.
Strong attention to detail.
Ability to identify inconsistencies or potential quality issues.
Ability to make appropriate observations and escalate issues when required.
Communication and Collaboration Skills
Excellent written and verbal communication skills.
Strong interpersonal skills.
Ability to work effectively with cross-functional teams.
Ability to communicate safety information clearly.
Ability to collaborate with internal and external stakeholders.
Ability to provide guidance and training to colleagues.
Key Competencies
Pharmacovigilance Operations
Drug Safety
Safety Reporting
PSUR Preparation
ICSR Reporting
Adverse Event Reporting
Safety Data Analysis
Regulatory Compliance
Quality Management
Regulatory Intelligence
Stakeholder Management
Training and Knowledge Sharing
Attention to Detail
Communication
Team Collaboration
Ideal Candidate Profile
The ideal candidate is a pharmacovigilance professional with strong drug safety and safety reporting experience, capable of preparing high-quality regulatory safety reports and analyzing safety data.
The candidate should be comfortable working with cross-functional teams, managing regulatory timelines, interpreting safety information, and maintaining compliance with pharmacovigilance regulations and internal procedures.
Experience with PSURs, ICSRs, adverse event reporting, safety data analysis, and regulatory submissions would be particularly relevant.
Locations
The position is available in:
Chennai, India
Trivandrum, India
Bangalore, India
Mexico City, Mexico
Work Arrangement
Office or Home
Employment Requirement
Employment with ICON is contingent upon the candidate having the legal right to work in the country where the role is based.
Benefits
ICON may offer a comprehensive rewards package that can include:
Competitive base salary
Performance-related incentives
Health and wellbeing programs
Medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programs
Wellbeing resources
Learning and development opportunities
Structured training and career development pathways
Benefits may vary depending on role and location.
Inclusion and Accessibility
ICON is committed to building an inclusive and accessible workplace where employees feel valued and supported.
Reasonable accommodations are available during the recruitment process for candidates who require assistance.
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