# Pharmacovigilance Specialist

**Company**: Unspecified Company
**Experience**: entry
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Dalian/Submission-Specialist_266086?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_594b4a7c-48f

## 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.

## Skills

### Required
- Pharmacovigilance
- Regulatory Compliance
- ICSR Reporting
- Data Entry
- Problem-Solving
- Time Management
- Attention to Detail

### Nice to have
- Experience with SOPs
- Working knowledge of pharmacovigilance agreements

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Dalian/Submission-Specialist_266086?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)