Job Vacancy
Pharmacovigilance Officer - مسؤول اليقظة الدوائية
المسمى الوظيفي / Job Title:
مسؤول اليقظة الدوائية – Pharmacovigilance Officer
القسم / Department:
الشؤون التنظيمية والجودة – Regulatory & Quality (Pharmacovigilance)
خط التقارير / Reporting Line:
المدير المباشر – قسم الشؤون التنظيمية والجودة
Direct report to: Regulatory & Quality Manager
الغرض من الوظيفة / Job Purpose
ضمان متابعة ورصد وتوثيق الآثار الجانبية للمنتجات الدوائية بما يتوافق مع المتطلبات القانونية والمعايير الدولية، بهدف تعزيز سلامة المرضى وضمان الالتزام باللوائح التنظيمية.
Ensure monitoring, recording, and reporting of adverse drug reactions in compliance with local regulations and international standards, contributing to patient safety and regulatory compliance.
المهام والمسؤوليات الرئيسية / Key Responsibilities
Adverse Event (AE) Management
Collect, evaluate, and process adverse event reports from healthcare professionals, patients, internal staff, and literature.
Ensure timely entry of AE/SAE (serious adverse event) data into safety databases.
Perform case triage, medical coding (e.g., MedDRA), and narrative writing.
Safety Data Review
Assess individual case safety reports (ICSRs) for completeness, accuracy, and consistency.
Identify potential safety signals and trends.
Support aggregate data analysis for periodic safety updates.
Regulatory Compliance
Ensure compliance with global and local pharmacovigilance regulations (e.g., IPC, EMA, FDA, MHRA, ICH).
Assist in preparing and submitting expedited safety reports (e.g., SUSARs).
Contribute to the preparation of regulatory safety reports (PSURs, PBRERs, DSURs).
Signal Detection & Risk Management
Participate in signal detection activities and risk-benefit assessments.
Support the development and implementation of Risk Management Plans (RMPs).
Collaboration & Communication
Liaise with clinical, regulatory, quality assurance, and medical teams on safety issues.
Support audits and inspections by regulatory authorities.
Communicate safety findings to stakeholders in clear, compliant formats.
Documentation & Quality Assurance
Maintain accurate records of pharmacovigilance activities.
Contribute to SOP development and updates.
Participate in quality checks, audits, and process improvement initiatives.
Training & Development
Train internal staff on pharmacovigilance requirements.
Keep up to date with changes in global and local PV regulations and best practices.
Qualifications & Requirements
· Bachelor’s degree in pharmacy.
· Minimum of 2–5 years’ experience in pharmacovigilance or regulatory affairs.
· Good knowledge of local regulations and international PV guidelines.
· Proficiency in English (reading, writing, and speaking).
· Strong computer skills (MS Office – Excel, Word, PowerPoint).
Personal Attributes
· High attention to detail and accuracy.
· Strong communication and teamwork skills.
· Commitment to confidentiality and compliance with regulations.