Pharmacovigilance Reporting Specialist
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Job Description
Pharmacovigilance Reporting Specialist preparing PSURs and ICSRs for ICON, a global healthcare intelligence and clinical research organization. Analyzing safety data and ensuring regulatory-compliant drug safety reporting.
Responsibilities:
- Prepare and submit comprehensive safety reports, including periodic safety update reports (PSURs) and individual case safety reports (ICSRs), in compliance with regulatory standards
- Conduct thorough data analysis to identify trends and assess the safety profile of pharmaceutical products
- Collaborate with cross-functional teams to ensure timely and accurate reporting of adverse events
- Maintain up-to-date knowledge of pharmacovigilance regulations and industry best practices to ensure compliance
- Provide training and support to team members on pharmacovigilance reporting processes and requirements
- Contribute to pharmacovigilance and drug safety activities, taking responsibility for deliverables and working collaboratively
Requirements:
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Significant experience in pharmacovigilance reporting or drug safety within a clinical or pharmaceutical environment
- Strong analytical skills with proficiency in data analysis tools and reporting software
- Excellent communication and interpersonal skills, facilitating effective collaboration with internal and external stakeholders
- A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities
- Legal right to work in the country where the role is based
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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