Senior Pharmacovigilance Specialist

Green Portfolio Project; United Arab Emirates; Hybride; AED 280 000 - 420 000; Plein temps

Résumé du poste

Green Portfolio Project seeks a Senior Pharmacovigilance Specialist in the UAE to oversee adverse event processing, regulatory reporting, and risk management across the product lifecycle. You will ensure data integrity and regulatory compliance while coordinating with QA, medical, and regulatory teams.

The role requires 5–8 years in pharmacovigilance, familiarity with UAE requirements and ICH/GVP guidelines, and experience with safety databases (e.g., Argus).

Qualifications

• Bachelor's or Master's degree in Pharmacy, Pharmacology, Medicine, Life Sciences, Biomedical Science, or a related discipline.
• Experience 5–8 years in pharmacovigilance, drug safety, regulatory affairs, or clinical safety operations.
• Strong understanding of adverse event reporting, ICSRs, and safety signal management.
• Familiarity with UAE pharmacovigilance regs and ICH/GVP guidelines.

Responsabilités

• Adverse Event Management: receive, review, assess, and process adverse event reports.
• Case Processing: ensure accurate intake, data entry, assessment, coding, follow-up, documentation.
• Causality Assessment: evaluate relationships between medicines and events.
• Regulatory Reporting: prepare and submit ICSRs within timelines.
• Safety Signal Detection: monitor databases, literature, and reports for signals.
• Risk Management: contribute to risk management plans and risk minimization.
• PSURs/PBRERs: support preparation and review of periodic safety reports.
• Literature Surveillance: conduct regular literature searches for reportable events.
• Regulatory Compliance: ensure PV activities comply with UAE and international guidelines.
• Safety Database Management: maintain PV records with data integrity and confidentiality.
• Quality Assurance: review safety case docs and ensure accuracy.
• Signal Evaluation: collaborate to assess safety concerns and follow-up actions.
• Inspection Readiness: prepare PV docs for regulatory inspections and audits.
• SOP Development: update safety reporting processes and procedures.
• Vendor Coordination: work with CROs and partners to ensure reporting obligations.
• Training and Mentoring: guide junior staff and train on PV processes.
• Safety Agreements: review PV agreements and define responsibilities.
• Continuous Improvement: identify opportunities to improve PV processes.

Connaissances

Adverse Event Mgmt

Case Processing

Causality Assessment

Regulatory Reporting

Safety Signal Detection

Risk Management

PSURs/PBRERs

Literature Surveillance

Regulatory Compliance

Safety Database Management

Quality Assurance

Inspection Readiness

SOP Development

Vendor Coordination

Training & Mentoring

Safety Agreements

Continuous Improvement

Formation

Bachelor's or Master's degree in Pharmacy/Pharmacology/Life Sciences/Medicine

Outils

Argus Safety

Description du poste

Job Title: Senior Pharmacovigilance Specialist

Location: UAE

Employment Type: Full-Time

Work Arrangement: On-Site / Hybrid, depending on business requirements

Level: Senior

About Us

We are seeking an experienced and detail-oriented Senior Pharmacovigilance Specialist to support drug safety monitoring, adverse event reporting, and risk management activities throughout the pharmaceutical product lifecycle. The successful candidate will help ensure the safety of medicinal products by evaluating adverse event reports, maintaining pharmacovigilance documentation, monitoring emerging safety signals, and ensuring compliance with applicable UAE regulatory requirements and international pharmacovigilance standards.

The ideal candidate will possess strong scientific knowledge, analytical skills, and a thorough understanding of drug safety procedures, regulatory reporting obligations, and patient safety principles.

Key Responsibilities

• Adverse Event Management: Receive, review, assess, and process adverse event reports from healthcare professionals, patients, clinical studies, and other relevant sources.
• Case Processing: Ensure accurate case intake, data entry, medical information assessment, coding, follow-up, and documentation in accordance with established procedures.
• Causality Assessment: Support the evaluation of potential relationships between medicinal products and reported adverse events using appropriate scientific and clinical criteria.
• Regulatory Reporting: Prepare and submit individual case safety reports (ICSRs) within applicable regulatory timelines and reporting requirements.
• Safety Signal Detection: Monitor safety databases, scientific literature, clinical data, and post-marketing reports to identify potential safety signals.
• Risk Management: Contribute to the development, review, and implementation of risk management plans and risk minimization measures.
• Periodic Safety Reports: Support the preparation and review of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and other applicable safety reports.
• Literature Surveillance: Conduct regular searches of relevant medical and scientific literature to identify reportable adverse events and emerging safety information.
• Regulatory Compliance: Ensure pharmacovigilance activities comply with applicable UAE health authority requirements, relevant international guidelines, and company procedures.
• Safety Database Management: Maintain accurate and complete pharmacovigilance records, ensuring data integrity, traceability, and appropriate confidentiality.
• Quality Assurance: Review safety case documentation, identify inconsistencies, and support quality checks to maintain high standards of accuracy and completeness.
• Signal Evaluation: Collaborate with medical, regulatory, clinical, and quality teams to assess potential safety concerns and recommend appropriate follow-up actions.
• Inspection Readiness: Prepare pharmacovigilance documentation and evidence for regulatory inspections, internal audits, and external assessments.
• SOP Development: Develop, review, and update standard operating procedures, work instructions, and safety reporting processes.
• Vendor Coordination: Coordinate with contract research organizations, pharmacovigilance service providers, distributors, and other partners to ensure compliance with safety reporting obligations.
• Training and Mentoring: Provide guidance to junior pharmacovigilance staff and support training on case processing, safety reporting, and regulatory procedures.
• Safety Agreements: Support the review and maintenance of pharmacovigilance agreements and ensure responsibilities are clearly defined and followed.
• Continuous Improvement: Identify opportunities to improve case processing efficiency, reporting accuracy, safety surveillance, and pharmacovigilance quality systems.

Qualifications and Experience

• Bachelor's or Master's degree in Pharmacy, Pharmacology, Medicine, Life Sciences, Biomedical Science, or a related discipline.
• At least 5–8 years of relevant experience in pharmacovigilance, drug safety, pharmaceutical regulatory affairs, or clinical safety operations.
• Strong understanding of adverse event reporting, individual case safety report processing, causality assessment, and safety signal management.
• Familiarity with applicable UAE pharmacovigilance regulations and relevant international guidelines, including ICH and GVP requirements where applicable.
• Experience preparing or reviewing periodic safety reports, risk management plans, and regulatory safety documentation.
• Knowledge of MedDRA terminology, WHO Drug coding, and pharmacovigilance case processing standards.
• Experience using safety databases and pharmacovigilance systems such as Argus Safety or equivalent platforms.
• Strong scientific literature review, data analysis, and medical documentation skills.
• Excellent written and verbal communication skills, with the ability to prepare clear and accurate safety reports.
• Strong organizational skills and the ability to manage multiple cases and regulatory deadlines.
• High standards of accuracy, confidentiality, data integrity, and professional ethics.
• Experience supporting pharmacovigilance audits, regulatory inspections, and quality management activities.
• Relevant pharmacovigilance, clinical research, or regulatory affairs certifications are an advantage.
• Ability to work collaboratively with medical, regulatory, quality assurance, and clinical teams.

Key Performance Indicators (KPIs)

Performance will be evaluated against agreed drug safety, regulatory compliance, and operational objectives, including:

• Case Processing Accuracy: Maintain accurate, complete, and consistent adverse event case documentation.
• Regulatory Timeliness: Submit reportable safety cases and required documentation within applicable deadlines.
• Compliance Performance: Maintain adherence to relevant pharmacovigilance regulations, reporting requirements, and internal procedures.
• Signal Detection Effectiveness: Identify and elevate potential safety signals in a timely and scientifically appropriate manner.
• Report Quality: Ensure periodic safety reports and other regulatory submissions meet established quality standards.
• Database Integrity: Maintain complete, accurate, and traceable pharmacovigilance records.
• Quality Assurance: Reduce avoidable case processing errors and recurring documentation deficiencies.
• Audit Readiness: Maintain organized documentation and support timely resolution of audit findings.
• Literature Surveillance: Complete assigned literature monitoring and safety review activities within established timelines.
• Vendor Performance: Monitor the quality and timeliness of outsourced pharmacovigilance activities where applicable.
• Team Development: Support staff training, technical competency, and consistent application of safety procedures.
• Process Improvement: Improve case processing efficiency, reporting quality, and overall pharmacovigilance performance.

What We Offer

• Competitive salary based on qualifications and experience.
• Opportunities to work on pharmaceutical drug safety and regulatory compliance activities.
• Professional development and continuing education in pharmacovigilance and patient safety.
• Exposure to international drug safety standards and regulatory processes.
• Opportunities for career advancement into pharmacovigilance management, drug safety leadership, or regulatory affairs.
• A collaborative working environment focused on scientific integrity, patient safety, and continuous improvement.