Senior Adverse Event Processing Specialist

🏗 We're Hiring: Senior Adverse Event Processing Specialist

📍 Location: United Arab Emirates (Remote)

🕒 Employment Type: Full-Time

💼 Experience Level: Mid-Level to Senior

🌐 Work Arrangement: Fully Remote

About Us

We are a construction-focused organization committed to delivering complex projects through disciplined contract management, commercial excellence, risk control, and collaborative project delivery. Our distributed teams collaborate across Project Management, Construction, Engineering, Procurement, Commercial, Legal, Finance, Human Resources, Design, Quality, HSE, Consultants, Contractors, Suppliers, Logistics, Administration, Information Technology, and Executive Leadership to maintain high standards of operational excellence, regulatory compliance, risk management, and business continuity.

We also recognize the importance of effective safety reporting, product and service quality oversight, incident documentation, and structured risk assessment across our broader operational and business activities. Through consistent procedures, accurate records, timely escalation, and continuous improvement, we aim to strengthen organizational accountability and support informed decision-making.

The Role

We are seeking an experienced Senior Adverse Event Processing Specialist to support the accurate, timely, and compliant processing of adverse event reports within a pharmacovigilance and drug safety environment. The successful candidate will manage adverse event case intake, data entry, case assessment, coding, documentation, quality review, follow-up coordination, and regulatory reporting activities in accordance with applicable requirements, established procedures, and safety reporting timelines.

This role requires strong knowledge of pharmacovigilance processes, adverse event terminology, safety databases, medical documentation, and regulatory compliance. The specialist will work closely with Drug Safety, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Clinical Operations, Quality Assurance, and other stakeholders to maintain the integrity of individual case safety reports (ICSRs), support signal detection activities, and contribute to the continuous improvement of safety operations.

Key Responsibilities

• Manage the end-to-end processing of individual case safety reports arising from clinical trials, post-marketing surveillance, patient support programs, medical information inquiries, literature monitoring, and other approved safety data sources.
• Receive, register, classify, and process adverse event reports in accordance with established pharmacovigilance procedures.
• Review incoming safety information to identify potential adverse events, adverse drug reactions, medication errors, product quality complaints associated with safety concerns, and other reportable safety information.
• Determine whether incoming information meets the applicable minimum criteria for a valid individual case safety report.
• Verify the presence and adequacy of essential case elements, including an identifiable patient, identifiable reporter, suspect medicinal product, and suspected adverse event or reaction.
• Record initial receipt dates, awareness dates, follow-up dates, and other relevant case milestones accurately.
• Maintain appropriate documentation of case receipt, source information, processing decisions, and subsequent case updates.
• Enter adverse event information into designated pharmacovigilance and safety databases accurately and consistently.
• Ensure all relevant case information is captured in structured database fields and supporting narrative documentation.
• Review source documents, medical records, laboratory results, discharge summaries, clinical notes, and other supporting information relevant to adverse event reports.
• Extract clinically relevant information from source documents while preserving the original meaning and context.
• Prepare clear, concise, medically coherent case narratives using approved conventions and organizational standards.
• Ensure case narratives accurately reflect the reported event, patient history, suspect product exposure, treatment information, clinical course, and available outcomes.
• Identify missing, inconsistent, duplicated, or unclear information and determine appropriate follow-up requirements.
• Perform duplicate case checks to identify potential duplicate reports across databases, reporting channels, products, regions, and safety partners.
• Resolve potential duplicate cases in accordance with approved procedures and maintain appropriate cross-referencing.
• Code adverse events, medical histories, indications, and relevant medical conditions using the Medical Dictionary for Regulatory Activities (MedDRA) or other approved terminology.
• Code medicinal products using the applicable product dictionaries and organizational coding conventions.
• Apply standardized terminology consistently while preserving the clinical meaning of the source information.
• Review coding selections for accuracy, specificity, consistency, and alignment with documented clinical information.
• Identify ambiguous medical terms and escalate cases requiring clarification or medical review.
• Assess seriousness criteria based on available information, including death, life-threatening events, hospitalization, disability, congenital anomalies, and other medically significant conditions.
• Document seriousness assessments and the supporting rationale in accordance with applicable requirements.
• Support the assessment of expectedness or listedness against the relevant reference safety information and approved product documentation.
• Assist with determining reportability based on the applicable product, study, jurisdiction, reporting category, and regulatory requirements.
• Identify cases requiring expedited reporting and escalate them promptly to the responsible pharmacovigilance or regulatory reporting team.
• Track applicable reporting deadlines and support the timely preparation and submission of safety reports.
• Ensure that case processing priorities reflect regulatory timelines, seriousness, source type, and established service-level agreements.
• Process initial, follow-up, and nullification cases in accordance with approved workflows and case management requirements.
• Update existing safety cases when additional clinical, product, reporter, or outcome information becomes available.
• Review follow-up information to determine whether it changes case validity, seriousness, expectedness, causality information, or reporting obligations.
• Coordinate follow-up requests with reporters, healthcare professionals, clinical sites, investigators, patients, caregivers, and other authorized contacts as appropriate.
• Prepare focused follow-up questions to obtain missing or clinically relevant information.
• Document follow-up attempts, responses, outstanding questions, and case closure decisions.
• Handle cases involving special situations, including pregnancy exposure, breastfeeding exposure, overdose, misuse, abuse, medication errors, off-label use, occupational exposure, lack of efficacy, and product interactions, as applicable.
• Identify and appropriately process adverse events associated with special populations, including pediatric patients, older adults, and other groups requiring particular consideration.
• Process cases involving multiple suspect products, concomitant medications, complex treatment histories, or multiple reported events.
• Support the processing of serious adverse events arising from clinical trials in coordination with clinical safety and study management teams.
• Review investigator reports and supporting clinical trial documentation for completeness and consistency.
• Apply study-specific safety processing requirements while maintaining alignment with applicable clinical trial regulations and approved protocols.
• Process post-marketing safety reports received from consumers, healthcare professionals, distributors, business partners, and other authorized sources.
• Support literature case processing by reviewing relevant publications and identifying reportable safety information.
• Ensure that the source publication, bibliographic details, and relevant clinical information are accurately documented.
• Review safety information received through product complaints, medical information channels, and other internal reporting pathways.
• Coordinate with Quality Assurance and Product Quality teams when an adverse event report is associated with a suspected product defect or quality issue.
• Recognize cases involving potential medication errors, product misuse, counterfeit products, or other safety concerns and escalate them according to established procedures.
• Maintain confidentiality and appropriate access controls when handling patient information, medical records, reporter details, and sensitive safety data.
• Apply data privacy and information security requirements when receiving, storing, transferring, reviewing, and reporting adverse event information.