We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Safety Specialist to join our growing team!

The Safety Specialist is an integral part of the safety team and performs all aspects of the collection, processing, and reporting of individual case safety reports (ICSR) for clinical trials and/or post‑marketing programs.

Main Duties & Responsibilities:

• Process ICSRs according to SOPs and project-specific safety plans
• Triages ICSRs, evaluates data for completeness and regulatory reportability
• Enter data into Argus Safety Database
• Code events, medical history, concomitant meds, and tests
• Draft case narratives
• Query resolution and follow‑up until complete
• Generate timely expedited regulatory reports
• Coordinate reconciliation of safety and clinical databases
• Ensure required safety reports distribution
• Participate in audits/inspections
• Submit documents to TMF/PV System MF
• Maintain compliance with SOPs, GCP, ICH, GVP, regulations
• Attend department meetings
• Participate in project meetings
• Other duties as assigned

Education and Experience:

Minimum Education & Experience:

• Minimum 2 years clinical trial drug safety experience; Bachelor’s degree in Pharmacy, Nursing, Life Science, or equivalent. Experience with Argus Safety Database, MedDRA, WHODrug, FDA/EMA/ICH safety regulations
• Professional working proficiency in English

Preferred Education & Experience:

• Early phase oncology experience preferred

Knowledge, Skills, and Competencies:

• Strong knowledge of safety reporting requirements and guidelines
• Ability to analyze and evaluate clinical safety data
• Strong written communication and narrative writing skills
• Experience with Argus, MedDRA, WHODrug
• Strong attention to detail
• Ability to manage multiple cases and deadlines

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru and seeking a Clinical Systems Administrator to join our growing team!

The primary responsibility of the Clinical Systems Administrator is to provide business administration support for the Sponsor’s clinical systems, including but not limited to eTMF/CTMS, IRT and EDC systems (i.e., Veeva Clinical Vault and Medidata CTMS). The Clinical Systems Administrator will work with the Clinical Systems leadership and Project teams to ensure on-time deliverables and provide clinical systems user support as outlined below.

Essential functions of the job include but are not limited to:

• Responsible for User Access management for internal, sponsor and 3rd party access requests to the Clinical Systems and other business systems.
• Manages the data entry into the Global Directory within Precisions Clinical System of all Sites, Institutions and update as required.
• Manages the creation of studies, countries and sites within the Clinical System
• Responsible for resolving help desk tickets assigned, either by answering questions, trouble shoot problems or identify system performance issues or deficiencies.
• Perform Clinical System modifications and updates to picklists, field requirements
• Manages the review of Clinical System processes and procedures
• Supports with initiating the integrations between the Clinical system and Electronic Data Capture system
• Performs archival steps within the Clinical System as the request was received.
• Support the leads or manager in any ad-hoc tasks assigned.

Qualifications:

Minimum Required:

• Degree, or equivalent experience ideally in a business, scientific or healthcare discipline
• 2 years’ clinical trial experience with 2 years of experience with Clinical Systems
• Professional working proficiency in English

Other Required:

• Experience in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations.

Preferred:

• Demonstrate skills in effective communication (written, oral, and presentation) to all levels including end-users, vendors, and Management Teams.
• Possess the ability to effectively communicate business needs to IT technology partners.

Skills:

• Ability to resolve issues independently with good judgement to escalate appropriately.
• Ability to learn new systems and integration requirements.
• Strong interpersonal, verbal and written communication skills