ATISH SHAHARE

• Prepared and reviewed Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), ACO, Risk Minimization Plans (RMPs), Risk Minimization Measures (RMMs), and safety signal reports as per the company's Standard Operating Procedures and Work Instructions.
• Reviewed with the physicians to conduct, and prepared signal detection reports.
• Performed medical writing and analysis of periodic, ad hoc aggregate safety data, and reports.
• Liaise with the Regulatory Affairs team and request brand names, generic names, country of submission, registration procedure, HA PSUR assessment report, and CDS for reference.
• Liaise with the Pharmacovigilance Data Management (PVDM) team to provide the Argus drug codes and line listings.
• Scheduled meetings with safety physicians to resolve report-related queries, and to prepare a submission-ready draft report.
• Liaised with pre-clinical, clinical, regulatory, and relevant stakeholders for the inputs required for the PSUR.
• Ensured the completeness and accuracy of the source documentation provided for the PSUR.
• Notified the case processing team to process relevant cases as per the PSUR schedule.
• Addressed all the comments received from all the stakeholders, including the QC reviewer.
• Ensured consistency in formatting before submission.
• Non-EEA safety trigger searches contribute to APAC (Australia, Japan, New Zealand, India, and WHO).
• Contribution towards other activities, such as the Clinical Overview Addendum (COA) and Response to Query requests from the health authority.
• Responsibility for authoring reference safety information.
• Functional Area: Safety Surveillance, and Risk Management.
• Identified areas for improvement within the department, implementing strategic initiatives to address gaps in performance or resources.
• Improved team efficiency by streamlining processes and implementing innovative management strategies.

• Acknowledging receipt of ICSRs to the sender within the timelines documented in the relevant SOP.
• Accountable for sending queries for clarity, associated with incoming information, if required.
• Handling invalid items in IRT appropriately through reference to SOPs, relevant training, and the ARIS-G user manual.
• Accountable for performing accurate data capture for individual case safety reports, which can be spontaneous, clinical, literature, or legal in origin.
• Accountable for performing the appropriate clinical assessments (including the assessment of seriousness, labeling, and company causality for each adverse event), adhering to SOPs, other controlled documents, and regulatory requirements.
• Responsible for identifying duplicate or invalid ICSRs in ARIS-G and handling them as per the relevant SOP.
• Accountable for reviewing and assessing the validity of literature abstracts and articles, with further processing onto the safety database as required.
• Responsible for generating and forwarding appropriate queries and requests for clarification and/or follow-up information.
• Functional Area: Pharmacovigilance / Drug Safety.
• Collaborated with global partners in sharing pharmacovigilance information efficiently while respecting privacy and confidentiality requirements.
• Implemented process improvements that increased overall team productivity while maintaining high-quality standards for safety reporting.

• Receive information on adverse events; perform initial checks to meet the valid case report criteria.
• Search the database to prevent duplicate entries, create a case file, and initialize received drug safety reports in the ARGUS safety database.
• Ensure scientific rigor through accurate, complete, and consistent data entry of adverse event reports from the source document, with emphasis on timelines and quality.
• Evaluate and process the adverse event reports, including a review for completeness and accuracy.
• Narratives are written by summarizing the essential case details and using medical dictionaries and business guidance for coding and labeling of the adverse event.
• Identify clinically relevant information missing from the case report, and facilitate its collection by follow-up requests as needed.
• Ensure all the ICSR are processed in compliance with the regulatory requirements, and as per the SOP, within the timelines.
• Documentation of all the case-related source documents and communications.
• Functional Area: Pharmacovigilance, Drug Safety, and Epidemiology.
• Excellent communication skills, both verbal and written.
• Self-motivated, with a strong sense of personal responsibility.

• Interfacing with a multi-faceted clinical project team to achieve successful clinical studies within appropriate timeframes.
• Communicating project progress, challenges, and opportunities on a regular basis to Clinical Leadership both verbally and in writing.
• Assisting in pre-study and site initiation planning, including investigator meetings, and clinical site recruitment.
• Assisting in maintaining the accuracy, thoroughness, and regulatory compliance of clinical documentation.
• Conducted clinical trial in accordance with protocol and recorded and monitored progress.
• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.

GPA: First Class

• Board/University: Sant Gadge Baba Amravati University
• GPA: Second Class

• Board/University: Nagpur Board
• GPA: Second Class

• Board/University: Nagpur Board
• GPA: Second Class