PV Coordinator

Position Overview

• Location Type: Office
• Job Type: Full-time
• Work Schedule: Standard (Mon-Fri)
• Salary: Not specified

Thermo Fisher Scientific is seeking an administrative professional to provide support to the Pharmacovigilance department. This role is crucial for ensuring the accurate and timely processing, tracking, filing, and archiving of safety reports. The position involves general administrative duties and participation in projects related to safety reporting, with potential for mentoring new staff.

A Day in the Life

• Safety Report Management: Responsible for submitting safety reports, scanning, indexing, filing (electronic and paper), completing and quality-checking safety trackers, and archiving in accordance with SOPs and WPDs. Resolving minor submission issues with minimal supervision.
• Cross-Departmental Support: Assisting and liaising with various teams on administrative safety reporting tasks, including audit readiness, meeting organization, minute-taking, filing, photocopying, work distribution, report reconciliation, completing metrics, and updating PPD systems with project allocations.
• Data Extraction and Maintenance: Extracting and collating reporting information from the Clinical Trial Management System. Maintaining and updating contact lists on PPD systems as directed by Safety Specialists.
• Initiative Support: Supporting departmental and Pharmacovigilance initiatives.
• Training: Training Pharmacovigilance department staff on safety reporting processes and associated PPD systems.
• Filing Support: Providing filing support for multiple projects, including barcoding, filing safety reports, identifying and reporting issues/inaccuracies to management, and maintaining the cleanliness and organization of the file room.
• File Review and Audits: Assisting with file reviews for completed safety reports, maintaining audit notification and file return notification forms, and supporting on-site audits as requested.
• Study File Coordination: Coordinating study files and inventories for clients, including distribution via postal services.

Requirements

• Education: Bachelor's degree in life science/healthcare-related fields (e.g., nursing, pharmacy, biology, med tech).
• Skills and Abilities:
  • Effective teamwork and ability to support leads and managers.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Access).
  • Solid understanding of procedural documents.
  • Excellent written and verbal communication skills, including professional phone and in-person interactions.
  • Exceptional organization and time management skills, with the ability to manage multiple tasks and handle stress effectively.
  • Strong attention to detail and accuracy.

Company Information

At Thermo Fisher Scientific, employees contribute to meaningful work that has a global impact. The company's mission is to enable customers to make the world healthier, cleaner, and safer. Thermo Fisher Scientific provides resources for career development and supports research, development, and delivery of life-changing therapies. Their PPD clinical research portfolio includes services across laboratory, digital, and decentralized clinical trials, with trials conducted in over 100 countries.