Description
We are seeking a Pharmacovigilance Specialist responsible for submitting Individual Case Safety Reports (ICSRs) to ensure compliance with global safety and Pharmacovigilance regulations.
Key Responsibilities:
- Report ICSRs from post-marketing and clinical trial sources to regulatory authorities.
- Distribute ICSRs to business partners according to pharmacovigilance agreements.
- Prepare ICSRs in various formats (xml, CIOMs, MedWatch, E2B gateway).
- Handle portal, courier, and manual submissions of ICSRs.
- Monitor submission workflows and track deadlines.
- Analyze E2B acknowledgments and perform quality checks.
- Support compliance investigations and track late cases.
- Provide metrics on submissions and resolve distribution issues.
- Assist with daily report reviews and ad hoc data analyses.
- Identify and escalate concerns requiring support desk intervention.
- May participate in audits or inspections.
Requirements:
- Intermediate IT skills and data entry experience.
- Ability to work independently, prioritize tasks, and manage time effectively.
- Strong problem-solving and decision-making skills.
- Proactive approach with attention to detail and quality orientation.
- Experience with Standard Operating Procedures (SOPs) and working practices.
- 1-3 years of relevant experience in pharmacovigilance or a related field.