Tejas Rana

• Accurate documentation of adverse events related to any company products.
• Supported inspections, visits and audits as well as CAPAs management.
• Oversaw adverse events case reporting and conducted follow-up.
• Providing follow-up with patients as well as health care providers to provide a full clinical picture of possible adverse drug events
• Responding to patients and healthcare professional inquiries within appropriate guidelines.
• Developed new or improved pharmacovigilance procedures.
• Assessed and distributed pharmaceutical product adverse event documents.
• Authored and managed regular safety update reports.
• Review data entered in safety database for completeness and accuracy.
• Full data entry including medical coding and safety narrative.
• Provide quality feedback to team resources.
• Track and maintain quality metrics.
• Mentor and guide the activities of the Dug Safety Associate.
• Reading, understanding, and adhering to organizational standard operating procedures (SOPs).
• Assisting in establishing and enforcing departmental standards.
• Quality review and peer review for a group.

• Provide accurate and timely responses to medical information inquiries from healthcare professionals and client.
• Initial book-in of case reports into safety database.
• Addition of Follow-up cases and follow-up pending cases.
• MedDRA coding of events and Drug coding as per company drug dictionary (CDD) and WHO drug dictionary.
• Processing of various types of ICSRs e.g., clinical trial cases, spontaneous cases, regulatory cases, solicited cases, etc. Argus safety database and ArisG database.
• Narrative checking.
• Routing the case to the appropriate workflow.
• Maintain proper systems to ensure compliance with reporting requirements. Ensure that all the records and documents are maintained as per specifications.
• Identify and document possible adverse drug events and product complaints.
• Provide medical writing and literature surveillance for the client as specified.
• Training of new staff members on standard operating procedures as needed.
• Oversaw adverse events case reporting and conducted follow-up.
• Developed new or improved pharmacovigilance procedures.
• Collaborating with client sales staff and medical liaisons in providing written responses to medical inquiries as needed.

Pharmacy