Safety Specialist

• Perform safety and pharmacovigilance program delivery activities, including collection, processing, and reporting of individual case safety reports (ICSRs)
• Conduct literature screening and review for safety, drug coding, drug dictionary maintenance, MedDRA coding, and safety data management
• Clean and validate xEVMPD product dictionary data; manually recode substance/product terms
• Manage duplicate ICSRs and perform quality review of ICSRs, SPOR/IDMP activities, substances, products, organisations, and referentials
• Prepare expedited and periodic safety reports in accordance with regulatory requirements
• Coordinate project workflow, team workload, deliverables, timelines, budgets, quality, and project risks/issues
• Assist with project plans, including Safety Management Plans, and participate in internal project review meetings
• Perform project setup, delivery, and close-out activities
• Enter and track information in SPVG quality and safety tracking systems and safety databases
• Triage ICSRs, assess completeness and accuracy, enter data, code events and medical information, write narratives, and resolve queries
• Coordinate reconciliation of safety data between clinical and safety databases
• Serve as a subject matter expert, resolve routine project queries, mentor and coach colleagues
• Manage a small project team when required
• Ensure distribution of required expedited and periodic reports to the Safety Submissions team when contracted
• Train investigators on ICSR reporting and project team members on relevant activities
• Participate in audits and inspections
• Maintain required documentation in the Trial Master File and Pharmacovigilance System Master File
• Apply SOPs, regulations, GCP, ICH guidelines, GVP, project plans, and regulatory intelligence to safety reporting activities

Explore Senior Safety & PV Specialist – Oversight of Pharmacovigilance… at Syneos Health. Review requirements and application details.

Safety Specialist jobs in Spain

Senior Safety & PV Specialist – Oversight of Pharmacovigilance Systems