Pharmacovigilance Coordinator

hace 1 semana

Buenos Aires, Argentina PSI CRO A tiempo completo

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 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)
- Prior experience in Clinical Research is a plus
- Administrative work experience
- Experience with safety databases is a plus
- Full working proficiency in English and Spanish
- Organizational and planning skills
- Detail-oriented, able to work 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.

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