Clinical Specialist

• Assure compliance with the Quality Management System
• Process ICSRs and Serious Adverse Events from clinical trials, including safety database entry, tracking, narrative writing, site follow-up requests, quality checks/review, and reporting to clients or agencies
• Perform reconciliation of safety data
• Participate in Project/Study Team meetings as the Safety and Pharmacovigilance representative
• Oversee planning, coordination, and quality review of aggregate safety reports
• Support preparation and submission of regulatory safety documents, including DSURs and 6MLL
• Supervise local handling, preparation, and submission of Periodic Safety Update Reports and Risk Management Plans and risk minimization activities
• Collaborate with medical, safety physicians, data management, IT, and other functions to ensure timely and accurate reporting or report delivery
• Act as Biomapas and/or contractual partners’ 24/7 local pharmacovigilance contact person or backup
• Monitor national and regional pharmacovigilance regulations
• Collect and process medical enquiries received through phone, email, fax, or other means
• Support weekly monitoring of local or global literature review
• Support continuous safety profile monitoring, detection of new signals, and evaluation
• Participate in inspections and audits, including post-inspection/audit support, when required

Explore Pharmacovigilance Specialist – Medical/Clinical Safety at Biomapas. Review requirements and application details.