Pharmacovigilance Coordinator

Company Description

PSI is a leading Contract Research Organization with more than 25 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

**Job Description**:
We are looking for a knowledgeable and proactive Pharmacovigilance Coordinator to join our enthusiastic and vibrant team.

In this role, you will provide day-to-day support to the company’s Pharmacovigilance Unit and process safety information throughout the course of a clinical trial. You will help to enhance patient care and safety in relation to the use of novel pharmaceuticals.

**The scope of responsibilities will include**:

- Timely distribution of project-specific Serious Adverse Event (SAE) and Immediately Reportable Adverse Events (IRAE) reports to project teams;
- Data entry into the safety database;
- Non-medical review of incoming SAE and IRAE reports;
- Maintenance and update of the company's project-specific SAE distribution lists;
- Review of project-specific SAE trackers maintained by PSI project teams with focus on their timely update;
- A contact point for Safety Desk and clinical project teams regarding SAE and IRAE reports flow and filing;
- Interaction with IT personnel pertaining to safety line maintenance;
- Maintenance of Pharmacovigilance files, calendars and schedules in an orderly manner.

**Qualifications**:

- College or University Degree (Biology or Bioscience is preferred);
- Administrative work experience is a plus;
- Experience with safety databases is a plus;
- Full working proficiency in English and Spanish;
- Organizational and planning skills;
- Detail-oriented, able to work with multiple tasks in a fast-paced environment;
- Communication and collaboration skills;

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.