Senior Pharmacovigilance Specialist
Company: Sin trabajo
- Location: United Arab Emirates
- Work mode: Remote
- Seniority: Senior
- Employment type: Full-time
- Posted: 7 days ago
- Offer language: English
Job description
🏗 We're Hiring: Senior Pharmacovigilance Specialist
Location: United Arab Emirates (Remote)
Employment Type: Full-Time
Experience Level: Mid-Level to Senior
Work Arrangement: Fully Remote
About Us
We are committed to operational excellence, regulatory compliance, risk management, and quality standards across our business activities and professional services.
The Role
We are seeking an experienced Senior Pharmacovigilance Specialist to oversee drug safety monitoring, adverse event reporting, safety data assessment, and pharmacovigilance compliance. The successful candidate will support patient safety by ensuring timely case processing, accurate safety documentation, and adherence to applicable UAE and international pharmacovigilance requirements.
Key Responsibilities
- Collect, assess, process, and document adverse drug reaction reports and safety cases.
- Review individual case safety reports (ICSRs) for accuracy, completeness, and consistency.
- Support timely submission of safety reports in accordance with applicable reporting requirements.
- Monitor adverse events, medication errors, product complaints, and other safety concerns.
- Conduct literature surveillance and review relevant safety information.
- Support signal detection, risk evaluation, and ongoing benefit-risk assessments.
- Maintain pharmacovigilance databases, safety records, and case documentation.
- Prepare periodic safety reports and contribute to risk management plans.
- Coordinate with Regulatory Affairs, Quality Assurance, Medical Affairs, and healthcare professionals.
- Ensure compliance with applicable UAE regulations and relevant international guidelines.
- Support pharmacovigilance audits, inspections, and corrective and preventive actions.
- Identify process improvements and provide guidance to junior team members.
Qualifications and Experience
- Bachelor's degree in Pharmacy, Medicine, Life Sciences, or a related field.
- Proven experience in pharmacovigilance, drug safety, or pharmaceutical regulatory compliance.
- Knowledge of adverse event reporting, ICH guidelines, and Good Pharmacovigilance Practices (GVP).
- Familiarity with UAE pharmacovigilance requirements is an advantage.
- Strong analytical, documentation, and communication skills.
Key Performance Indicators (KPIs)
- Accuracy and completeness of safety case processing.
- Timeliness of adverse event reporting.
- Compliance with pharmacovigilance procedures and regulations.
- Quality of safety documentation and audit readiness.
- Effective identification and escalation of safety concerns.
What We Offer
- Competitive salary based on experience.
- Professional development opportunities.
- A collaborative environment focused on medicine safety and regulatory compliance.
How to Apply
- Interested candidates are invited to submit their CV and relevant professional qualifications for consideration.
