Sr/safety Operations Specialist

hace 1 mes


Desde casa, México IQVIA A tiempo completo

**Job Overview**

**Essential Functions**
- Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
- Perform pharmacovigilance activities, including collecting and tracking incoming adverse events (AEs) and endpoint information.
- Determine initial/update status of incoming events, database entry, coding AEs and products, writing narratives, and performing literature-related activities.
- Conduct quality reviews, assist with reconciliation, case closure activities, and coordinate translations as per project timelines.
- Assess safety data for reportability to relevant authorities and track/report cases to regulatory bodies, ethics committees, and other oversight groups.
- Contribute to or lead deliverables in safety publishing, risk management, safety surveillance, and medical information.
- Ensure compliance with all project-related processes and activities, meeting quality, productivity, and delivery standards.
- Build a positive, collaborative team environment, providing training and mentoring for less experienced team members and operations staff.

**Qualifications**
- Bachelor’s degree in a scientific or healthcare discipline, or allied life sciences.
- At least 1 year in pharmacovigilance.
- ** Experience with case processing in Argus for clinical trial studies preferred.**
- Advanced level of English
- Excellent knowledge of medical terminology and applicable safety databases.
- Strong organizational skills, attention to detail, and the ability to manage multiple tasks and deadlines.

LI-Remote



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