Pooja Dhamale

• Responsible for processing safety data according to applicable regulations, guidelines, standard Operating procedures (SOPs) and project requirements and performing pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events(AE)/endpoint information.
• Ensuring that the AE and products are correctly coded in the database, writing clear and concise narratives, and performing all literature related activities (including citations review, triage and case processing) as per internal/ project timelines.
• Responsible for meeting quality standards, productivity, and delivery standards per project requirements.
• Ensuring submission of all reportable cases to regulatory authorities.
• Providing mentoring and shadowing to new associates, creating, maintaining, and tracking cases as applicable to the project plan.
• Communicating effectively with healthcare professionals regarding drug safety inquiries.
• Identifying areas of improvement in workplace health and safety protocols.
• ·Participating in internal audits of Drug Safety processes and procedures.

• Executed drug safety data management processes- combination of call intake, case intake, triage, case entry, medical coding, narrative writing, case follow-up.
• Ensured timely case processing of all valid and invalid (Spontaneous, MHRA, Literature and MLM cases) in Argus Database.
• Maintained accurate records of drug safety data in accordance with regulatory requirements.
• Identified areas of improvement in workplace health and safety protocols.
• Contributed to the development of Standard Operating Procedures related to Pharmacovigilance activities.
• Participated in internal audits of Drug Safety processes and procedures.
• Provided support in preparation for health authority inspections.
• Communicated effectively with healthcare professionals regarding Drug Safety inquiries.

· Performed case processing and end-to-end handling of cases in ARISg database (e.g. Spontaneous, Clinical trial, SUSAR, Non-intervention study, Non-interventional program, Malfunction, Combination product, Licensee partner, Product complaint cases)

· Monitored the timely completion of pharmacovigilance activities such as case processing and signal detection.

· Involved in Handling and reconciliation of safety mailbox.

· Conducted safety assessments of adverse event reports and identified potential signals for further evaluation.

· Performed assessment of adverse event reports for seriousness and listdeness by referring different labeling documents as per the process.

· Maintained a database of all reported adverse events, ensuring accuracy and completeness of records.

· Investigated serious adverse event reports received from investigators, healthcare providers or patients.

· Participated in training sessions with other team members on drug safety topics.