🛡️ Guardian of Patient Safety: Senior Pharmacovigilance Reporting Associate
Join ICON plc as a Senior Pharmacovigilance Reporting Associate and become the cornerstone of global drug safety compliance. This critical role places you at the forefront of safety data submission, where your expertise will ensure timely, accurate reporting that protects patients and maintains regulatory integrity worldwide.
As a world-leading healthcare intelligence organization, we're seeking an experienced PV reporting specialist with proven safety report submission experience. If you're passionate about pharmacovigilance excellence and excel in regulatory compliance, this is your opportunity to advance your career while ensuring the highest standards of drug safety monitoring and reporting.
🎯 Your Safety Reporting Mission: Key Responsibilities
Safety Report Submission Excellence
- Prepare and submit adverse event reports and comprehensive safety data with precision, ensuring 100% compliance with global regulatory requirements and internal policies
- Monitor and manage critical submission timelines, proactively addressing delays to maintain regulatory compliance
- Maintain meticulous documentation for all safety report submissions, ensuring audit readiness at all times
- Execute flawless periodic safety update reports (PSURs), annual reports, and regulatory documents
Data Analysis & Signal Management
- Collaborate with clinical and regulatory teams to review and analyze safety data, identifying emerging trends and potential safety signals
- Apply strong analytical skills to interpret complex safety data and determine appropriate reporting actions
- Contribute to safety signal detection activities and support risk management strategies
- Ensure data integrity through rigorous validation and quality control processes
Database Management & Quality Assurance
- Maintain and optimize pharmacovigilance databases, ensuring data accuracy and system functionality
- Perform meticulous data entry, validation, and reconciliation to support high-quality safety reporting
- Implement quality control measures to ensure database integrity and reporting accuracy
- Support database upgrades and validation activities as required
Team Leadership & Regulatory Readiness
- Provide comprehensive training and mentorship to junior team members on reporting procedures and pharmacovigilance regulations
- Engage actively in regulatory audits and inspections, ensuring full compliance and preparedness
- Stay current with evolving global regulatory guidelines and industry best practices
- Contribute to process improvements that enhance reporting efficiency and quality
⭐ Your Profile: PV Reporting Expertise
Essential Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred
- Extensive experience in pharmacovigilance or drug safety reporting with proven safety report submission track record
- Strong regulatory knowledge of global reporting requirements (FDA, EMA, MHRA, etc.)
- Proven expertise in preparing and submitting accurate adverse event reports and safety data
Technical Competencies
- Proficiency with pharmacovigilance databases (Argus, ARISg, Veeva Safety, etc.) and reporting tools
- Advanced skills in Microsoft Office Suite for data analysis and reporting
- Experience with PSUR preparation and regulatory document submissions
- Understanding of MedDRA coding and medical terminology
Professional Attributes
- Exceptional Analytical Skills: Ability to interpret safety data and identify trends requiring investigation
- Strong Communication: Excellent interpersonal skills for cross-functional collaboration
- Meticulous Attention to Detail: Commitment to accuracy in all reporting activities
- Project Management: Ability to manage multiple priorities in fast-paced environment
Regulatory & Compliance Expertise
- Knowledge of ICH guidelines and global pharmacovigilance regulations
- Experience with regulatory audit preparation and participation
- Understanding of risk management principles in pharmacovigilance
- Commitment to maintaining confidentiality with sensitive patient information
💫 Why Build Your PV Career at ICON?
Impact Global Patient Safety
- Play crucial role in protecting patient safety through accurate safety reporting
- Contribute to the safe use of medications across global populations
- Ensure regulatory compliance that supports drug development and market access
- Work on diverse therapeutic areas and complex safety profiles
Career Growth & Specialization
- Clear pathway to PV Team Lead and Safety Management roles
- Exposure to global pharmacovigilance operations and regulatory frameworks
- Opportunities for therapeutic area specialization and advanced certification
- Professional development in growing pharmacovigilance field
Collaborative Excellence
- Work with cross-functional teams including clinical, regulatory, and medical affairs
- Participate in global safety initiatives and process improvements
- Access to cutting-edge PV technology and reporting systems
- Supportive team environment with experienced PV professionals
Competitive ICON Benefits
- Attractive salary package with performance incentives
- Comprehensive health insurance for you and your family
- Global Employee Assistance Programme with 24/7 support
- Generous annual leave entitlements
- Retirement planning benefits and financial security
- Professional development allowance and training opportunities
- Supportive culture with focus on work-life integration
🚨 Safety Reporting Areas You'll Master
- Individual Case Safety Report (ICSR) Submissions
- Periodic Safety Update Report (PSUR) Preparation
- Regulatory Document Compliance & Submissions
- Safety Database Management & Quality Control
- Audit Preparation & Regulatory Inspection Support
✨ Ready to Lead Safety Reporting Excellence?
If you're an experienced pharmacovigilance professional with proven safety report submission expertise and commitment to regulatory compliance, we encourage you to apply. This Senior PV Reporting Associate role offers the unique opportunity to advance your career while ensuring the highest standards of drug safety monitoring and reporting worldwide.
Apply Now and become ICON's next Pharmacovigilance Reporting expert!
