Prachi Panaskar

• Evaluated safety profiles, wrote signal detection reports and monitored document filing and archiving.
• Oversaw adverse events case reporting and conducted follow-up.
• Reviewed, compiled and analyzed data for safety database management.
• Authored and managed regular safety update reports.
• Read scientific literature and bibliographic sources.
• Developed new or improved pharmacovigilance procedures.
• Supported inspections, visits and audits as well as CAPAs management.
• Trained staff and updated training documents to meet regulations and standards.
• Assessed and distributed pharmaceutical product adverse event documents.
• Conducted case reconciliation with internal departments, distributors, affiliates and business partners.
• Monitored deliverables for quality and adherence to regulatory reporting timelines.
• Assisted with preparation and implementation of pharmacovigilance agreements and contracts.
• Responded to requests from regulatory agencies and notified to share information.
• Liaised between quality control and other departments and contractors, providing project updates and consultation.
• Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
• Reviewed production processes and identified potential quality issues.
• Recorded and organized test data for report generation and analysis.
• Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
• Reported problems and concerns to management.
• Collected and analyzed data to measure effectiveness of quality control processes.
• Conducted data review and followed standard practices to find solutions.

Responsible for case intake, duplicate check, and registration.

· Received information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file (triage) and initialize received drug safety reports in tracking tool and/or safety database (book-in).

· Ensured scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality.

· Evaluated and finished processing of AE reports, including review for completeness and accuracy.

· Used medical dictionaries and business guidance's to code medical history, drugs and adverse event terms: Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For example MedDRA, NVS Company Product Dictionary, WHO-DD).

· Prepared narratives summarizing the essential details of the case with chronological manner.

· Identified clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed.

· Performed deletion and nullification of the invalid cases or concerned cases as per SMP/SOP.

· Worked with Novartis country safety departments, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and databased.

· Responsible POC for Product specific processing for Oncological Drug Kymriah.

Courses

Lean Six Sigma Yellow Belt at IQVIA Lean automation program

2022

Lean Six Sigma Foundations at LinkedIn Learning

2022

ICH GOOD CLINICAL PRACTICE E6 (R2) at The Global Health Network (Virtual: Self Reported)

2022

Junior

Languages

English Very good command Hindi Native speaker Marathi Native speaker

Solutions,

Hobbies

Reading books to explore knowledge and new things

Riding bikes

Explore new places, nature etc

· Processed/handled all types of reports soliciated and unsoliciated.

· Assist with related administrative and procedural activities as required or requested.

· Handled the mentees/new interns to get them out of QC as official mentor. · Provided support in reconciliation activities and audit as required and

acted like back-up lead.