Remote Pharmacovigilance Data Manager

Placements24; Randfontein; Remote; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Remote work flexibility

Health insurance

Retirement plan

Paid time off

Professional development

Conferences access

Job summary

Placements24 is seeking a highly skilled Remote Clinical Data Manager focused on pharmacovigilance. You will manage clinical trial data end-to-end, ensuring accuracy, data quality, and regulatory compliance, while working from home to support global drug safety initiatives.

The ideal candidate has 5+ years in clinical data management with 2+ years in pharmacovigilance and strong CDMS experience (Medidata Rave or Oracle Clinical).

Qualifications

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 5 years of progressive experience in clinical data management, with at least 2 years specifically in pharmacovigilance or drug safety
• Proficiency in clinical data management systems (CDMS) such as Medidata Rave, Oracle Clinical, or similar platforms
• Strong understanding of clinical trial processes, ICH-GCP guidelines, and pharmacovigilance regulations
• Experience with database design, data validation, and query management
• Excellent analytical, problem-solving, and organizational skills
• Proven ability to manage multiple projects simultaneously in a remote work environment
• Exceptional written and verbal communication skills

Responsibilities

• Oversee collection, validation, cleaning, and management of clinical trial data for pharmacovigilance studies.
• Develop and maintain clinical databases, ensuring adherence to data management plans and protocols.
• Perform data query generation and resolution with sites and study teams.
• Implement data quality control procedures and ensure data integrity throughout the study lifecycle.
• Manage data transfers and reconciliation activities, including SAE reconciliation.
• Prepare and review data management documentation (CRFs, validation specs, DB lock).
• Ensure compliance with regulatory requirements (ICH GCP, FDA, EMA) and SOPs.
• Collaborate with statisticians, programmers, and safety scientists for data analysis.
• Contribute to development and implementation of data management systems and tools.
• Train and mentor junior data management staff on best practices.

Skills

Pharmacovigilance data management

CDMS (Medidata Rave)

Remote collaboration

Education

Bachelor's degree in a scientific or healthcare-related field

Master's degree preferred

Tools

Medidata Rave

Oracle Clinical

Job description

Placements24 is seeking a highly skilled Remote Clinical Data Manager focused on pharmacovigilance. You will manage clinical trial data end-to-end, ensuring accuracy, data quality, and regulatory compliance, while working from home to support global drug safety initiatives.

The ideal candidate has 5+ years in clinical data management with 2+ years in pharmacovigilance and strong CDMS experience (Medidata Rave or Oracle Clinical).