Rachana Jadhav

Passionate, well organized & seasoned life science professional with hands on experience in the complete range of industry-related processes including ICSR data input, medical safety document analysis & composition, formulation, execution of standard operating procedures, narrative writing and corrective action plans for clients in multiple countries.

Drug Safety Specialist - Tata Consultancy Services - Mumbai

(2017-03 - 2023-05)

• Well trained in using ArisG, Argus, Sapphire and safety easy databases software, including pharmacovigilance terminology, MedDRA and WHODD.
• Accountable for recognizing, triaging, and reporting as per the program or manufacturer requirements.
• Served as a Subject Matter Expert during regulatory inspections, business partner audits and quality investigations.
• Ensured data accuracy, follow-up and reconciliation is completed on pharmacovigilance cases.
• Supported audit and inspections, medical information services and implement improvements for pharmacovigilance processes and procedures.
• Performed KPI (key performance indicators), prepared reconciliation reports and also participated in CAPA process. Identified root cause for late ICSR submissions, literature cases and provided appropriate corrective and preventive actions.
• Triaged and analyzed adverse events information for entry into the adverse event tracking and reporting system.
• Coded and classified adverse event reports according to regulations and department SOPs and work instructions as needed.
• Reporting and submitting reportable AEs to manufacturers as per reporting findings to appropriate stakeholders and regulatory agencies.
• Electronic filing and archiving of PV documents to maintain audit readiness at all times.
• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, and in accordance with client specific requirements and timelines focusing on triage, data entry, quality review and submissions workflow steps.
• Handled quality reviewer's positions and processed more than 6000 ICSR cases.
• Delivered quality review for data entries perform in safety database as per the reporting guideline documents and conduct pharmacovigilance training as required.
• Assist in the coordination of data entry on clinical research studies/clinical trials and configure reporting rules as per Health Canada regulations and client guidelines.

Medical Safety Specialist - Cognizant Technology Solutions - Mumbai

(2014-05 - 2017-02)

• Search the safety database (AEGIS 8. 2) for duplicate reports and evaluate case information for Medical Completeness.
• Timely submission of appropriate reports to global partners based on defined timelines as per the PVA.
• Managing with collection, processing, quality check and reporting of Safety events (initial and follow-up) as per the program requirements.
• Reconciliation activities for all types of reports received.
• The organization, accuracy, and completeness of pharmacovigilance information for a variety of manufacturers and Patient Support Programs, including audit preparation and management of AE/PV inbox.
• Performed data-entry, answer inbound calls, make outbound calls, manage e-mail, general administrative functions including faxing, filing.
• Participated in processes relating to regulatory or contractual reporting requirements.
• Proficient in the Microsoft Office Suite of products with the ability to work in various databases.
• Code the following fields using the most appropriate Lower Level Term (LLT) from MedRA: Medical history, Reported AEs, Other reported safety information (e.g. medication error, pregnancy, PQCs etc), indication for use of suspect and concomitant medications, labs and procedures, cause(s) of death.
• Assessed expectedness and create, updated case narrative and simultaneously processed vaccine cases too.
• Worked as a quality check (QC) the ICSRs. Perform QC to check completeness, timeliness, quality and accuracy of the processed cases.
• Reviewed and Approve adverse event reports for post-marketed products clarify medical issues ensure clear narrative, revise MedDRA terms and co-ordinate with external vendor and internal medical personnel as needed.
• Responsible for timely investigation, provided accurate and timely responses to Health authority.

Pharmacist - Wellness Forever Pharmacy - Mumbai

(2014-01 - 2014-04)

• Assist with billing needs
• Be familiar with stocked medications.
• Verifying prescriptions if applicable.
• Greet customers and answer basic questions.
• Coordinated with regular clients to refill prescriptions.

Post Graduate Diploma - Clinical Research & Pharmacovigilance - PGDCRPV

Bachelor - Pharmacy - University of Mumbai (2014)