Pharmacovigilance Medical Safety Specialist

Shoprite Group of Companies; Cape Town; Remote; ZAR 300,000 - 560,000; Full time

Job summary

Shoprite Group of Companies is seeking a Data Acquisition Specialist - External Data (Remote/Homebased) to define, set up and ingest External Data Streams for clinical trial data capture, ensuring alignment with protocol requirements.

The role involves liaising with data stakeholders, ensuring compliance with data protection laws, and creating Data Transfer Agreements and change requests for new data concepts.

Qualifications

• Experience with external data streams in clinical research.
• Knowledge of data protection laws and regulations.
• Strong stakeholder liaison and documentation skills.

Responsibilities

• Execute deliverables for Standardized External Data Streams.
• Assess external data collection requirements per protocol and plan setup activities.
• Liaise with key data stakeholders to define data transfer and structure.
• Create change requests for new data concepts or data structures.
• Develop trial-specific Data Transfer Agreements.

Job description

Data Acquisition Specialist - External Data (Remote/Homebased)

Bloemfontein, South Africa
Durban-Inland, KZN, South Africa
Centurion, South Africa
Bellville, South Africa
Full time
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The Data Acquisition Specialist performs activities relating to the definition, set-up and ingestion of External Data Streams, and related documents and processes aligned with Clinical Trial Protocol defined requirements for data capture.
External data streams include but are not limited to typical and novel data collected through central labs and ECG, medical imaging, biomarker and genomics analysis, real world data sources, EHR, electronic patient reported outcomes, wearables and sensors and other digital data collection technologies.

Deliverables

• Execute deliverables for Standardized External Data Streams.
• Assess external data collection requirements per protocol and planning of external data stream set-up activities and related deliverables to meet study start-up timelines.
• Liaise with key data stakeholders to establish the purpose of data collection and requirements for the transfer, ingestion, and structure of data for each data stream in compliance with applicable data protection laws and regulations, utilizing available standards and templates
• Create change requests for the definition of new test concepts or data structures relating to external data.
• Develop trial-specific Data Transfer Agreements