Pharmacovigilance Specialist
Role Overview
A healthcare organization is seeking a Pharmacovigilance (PV) professional to support drug safety operations related to both clinical development and marketed pharmaceutical products. The role involves handling safety information, supporting regulatory reporting processes, and assisting the project team with pharmacovigilance activities.
The successful candidate will contribute to maintaining high standards of drug safety monitoring while ensuring compliance with regulatory requirements.
Key Responsibilities
Pharmacovigilance Operations
Support safety management activities related to global clinical trials.
Manage safety information for investigational and marketed pharmaceutical products.
Safety Case Processing
Receive and review adverse event reports and other safety information.
Conduct case triage, data entry, and quality control of safety reports.
Prepare draft regulatory safety reports for submission to health authorities.
Maintain accurate documentation of safety data and reporting processes.
Safety Communication
Prepare safety line listings and related documentation for distribution to clinical trial sites.
Support communication of safety updates to relevant stakeholders.
Translation & Documentation
Translate safety-related documents between Japanese and English when required.
Ensure documentation accuracy and compliance with regulatory guidelines.
Project Support
Assist project team members with various operational and administrative tasks related to pharmacovigilance activities.
Required Qualifications
Professional Experience
Experience in pharmacovigilance operations (approximately 3+ years preferred).
Experience handling safety information for pharmaceutical products, including investigational and marketed drugs.
Practical experience managing Individual Case Safety Reports (ICSR), including activities such as:
Case intake
Data entry
Case evaluation
Translation
Quality control
Electronic transmission
Technical Knowledge
Understanding of the pharmacovigilance workflow, including adverse event processing and regulatory reporting requirements.
Ability to independently manage tasks and proactively support safety operations.
Language & Systems
Experience working in an English-language professional environment.
Basic proficiency in Microsoft Office applications (Excel, Word, Outlook).
Preferred Qualifications
Background as a healthcare professional such as a pharmacist, nurse, or other clinical professional.
Experience handling adverse event reporting related to medical devices.