Patient Safety Specialist at CDL Human Resource

Role Purpose: 

Support the management of Patient Safety operational processes at the Country Organization level, ensuring compliance with global and local procedures, as well as national and international regulations. This includes vigilance for marketed and investigational products (e.g., drugs, food supplements, medical devices) within our client's group.

Major Accountabilities:

• Manage adverse event reports across various sources (Clinical Trials, Non-interventional Studies, etc.), ensuring accurate and timely processing.
• Transcribe, translate, and enter data into safety systems, maintaining quality standards.
• Coordinate the submission and distribution of safety reports to Local Health Authorities and clinical operations.
• Develop and implement local procedures to align with global Patient Safety standards and local requirements.
• Collaborate with other departments (Medical Affairs, Marketing, etc.) to ensure compliance with vigilance requirements in relevant projects.
• Manage vigilance clauses in local contracts and agreements, advising stakeholders on necessary provisions.
• Reconcile adverse event data with other departments and third-party contractors as required.
• Maintain local Patient Safety databases and screen relevant literature articles.
• Prepare and submit compliance reports and KPIs, identifying and addressing any reporting delays.
• Develop and update training materials on vigilance procedures, ensuring training for relevant stakeholders.
• Support internal audits, Health Authority inspections, and implement corrective actions as needed.

Requirements

Ideal Background:

Education:

• Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience.

Experience/Professional Requirement:

• Knowledge of national and international regulations for pharmacovigilance

Knowledge of pharmacological and medical terminology

• Good communication and interpersonal skills
• Quality and results oriented
• Computer skills

Languages: Fluent in English and local language.

Key Performance Indicators:

• Quality and timely reporting of KPI and safety reports/updates.
• No critical findings in audits or inspections.
• Internal and external customer satisfaction.