Umar Gul Email & Phone Number

India

Delhi

-PV Mailbox Management•. Literature case processing • Assignment and tracking of documents received.• Perform Duplicate check.• Book-in/Intake and Triaging of ICSRs in Safety database and automated tool(s) as applicable• Translation Request Management• Perform Quality Review of cases• ICSR Merging and Deletion activity• Invalid Case Management• Health Authority Safety Information Download(s)Management• Robotic Process Automation adjudication• Handling of data corrections• Reconciliation activities• Audit and inspection support• Compliance to project guidelines• Compliance to assigned Training(s)• Execution of Company Standard Operating Procedures.• Builds and maintains good relationships across functional units and company affiliates.• Maintain awareness of changes to/new regulations affecting PVG activities.• To carry out necessary administrative duties required for the job.• Other duties as assigned by management.

Gurugram, Haryana, India

1. Enter data into safety database.2. Processing of ICSR according to standard operating procedure (SOP’s) and project /program specific safety plans.3. Evaluate ICSR data for completenss, accuracy and regulatory report ability. 4. Code events, medical history, concomitant medication and test.5. Identified information to be queried and follow up until information is obtained and queries are satisfactory resolved. 6. Maintains understanding and compliance with SOP’s, work instructions, ICH guidelines and drug development process. 7. Assessment of case reports for seriousness, casuality and expectedness.