REF 1816845
31.05.2025 | Abu Dhabi | full time
- General
- Location: Abu Dhabi
- Occupancy: full time
- Description
- About the Role - Work with the Pharmacovigilance (PV) team in processing adverse event and safety information, from intake to regulatory submission.
The PV Associate will support both the research and the post-marketing safety functional disciplines, across all therapeutic areas, domestic and global.
Responsibilities
* Perform intake and triage of safety information from all sources (e.g., subjects, patients, healthcare professionals, sales representatives, general public).
* Ensure that cases are accurately completed in a timely manner in accordance with appropriate SOPs (standard operating procedures), study protocols and regulatory guidelines.
* Ensure compliance with health authority regulations in drug safety data processing and reporting.
* Participate in the preparation and drafting of ad-hoc and aggregate regulatory reports (e.g., IND/DSUR/PADER/PSUR) and labeling support documents.
* Enter and track safety information in safety databases.
* Prepare regulatory safety reports, including individual case safety reports and narratives, summarizing all relevant medical information.
* Code medical terms using standardized medical dictionaries (e.g., MedDRA and WHO Drug); assist with establishing coding conventions.
* Participate in the review and reconciliation of data between safety databases and data migration activities.
* Review product complaints and assess for potential adverse events or any impact on subject safety.
* Recognize, prioritize and escalate potential safety/compliance issues.
* Conduct literature review activities related to adverse event reporting.
* Contribute to the preparation of regulatory responses, Investigator’s Brochure (IBs), study protocols, case report form, safety reports, and other documents as required.
* Provide information and assistance to medical/drug information staff (internal and/or external).
* Perform case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters (research and post-market).
* Liaise with clinical operations, medical/drug information, regulatory affairs, clinical research organizations (CRO), study sites, affiliates, and data management groups regarding safety data collection and data reconciliation as required.
* Additional responsibilities & projects as assigned.
- Requirements
- Experience with data analysis and reporting
Excellent verbal and written communication skills
Strong attention to detail
Proficient in Microsoft Office Suite and database management
- Provisions
- Salary: to be discussed
- Medical insurance provided
- Accommodation provided
- Publisher
- direct employer
- more than 200 employees