PV Specialist

As a PV Specialist, you will be integral to our pharmacovigilance efforts, handling key tasks such as :

• Data Entry :   Accurately input data into the PV database.
• Initial Assessment :   Perform initial assessments of Individual Case Safety Reports (ICSRs), as applicable.
• Expedited Reporting Evaluation :   Evaluate the necessity for expedited reporting to Health Authorities or client partners, including adherence to reporting timelines.
• Reporting Preparation :   Prepare standard reporting forms (e.g., CIOMS I, MedWatch Forms, and XML for submission.
• Follow-Up Requests :   Prepare and send follow-up requests to obtain additional information as necessary.
• ICSR Submission :   Submit ICSRs to Health Authorities and client partners, ensuring compliance with regulatory requirements.
• Case Completion :   Ensure thorough documentation and completion of cases.
• Quality Check :   Conduct quality checks on ICSRs to maintain data integrity.
• Search / Retrieval :   Perform the ICSR search and retrieval process from the EVWEB database and assess cases from both company and non-company sources.
• Case Management :   Allocate and manage cases effectively within the team.
• Training :   Provide training on the system to team members to enhance their operational capabilities.
• Additional Responsibilities :   Undertake other tasks as assigned by the Management team.

Your Profile :

Skills Required

Case Processing