SAIPREETHI G S

Drug Safety Professional

+1-510-***-****

ads25n@r.postjobfree.com

https://www.linkedin.com/in/saipreethi-senbaganathan-926a87251/

Summary:

•6 years of experience in Pharmaceutical industry with expertise in pharmacovigilance.

•Vast clinical and post marketing experience in individual case safety reporting (ICSR) and case submission to regulatory authorities.

•Applying good knowledge of applicable global, regional, local clinical research regulatory requirements including Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines.

•Review and monitoring of compliance through monitoring, ensuring, implementation of Corrective and Preventive Action (CAPA) plans.

•Solid Knowledge of US and ICH safety reporting regulations and guidelines.

•Triage, Data entry, creating new cases, searching for duplicate cases and extract information from the database.

•Serious Adverse Event (SAE) Reports Processing using Oracle Argus (V 8.0) and ArisG.

•Processing Suspected Unexpected Serious Adverse Reaction (SUSAR) cases, strictly compliant to 7-Day and 15-Day timelines.

•MedDRA coding, Narrative Writing and processing different cases.

•Assuring medically cohesive narrative with completeness and accuracy.

•Assessing causality and expectedness of adverse events as per documents like IB, EUSPC, CDS and USPI.

•Basic understanding of aggregate reporting and safety signal management.

Professional Experience:

Pharmacovigilance Scientist, Takeda Pharmaceuticals, Cambridge, Massachusetts

Dec 2017-Present

Processed and reviewed Serious Adverse Events (SAE) to ensure accurate and consistent data entry from source documents (spontaneous, PMS, clinical trials), with emphasis on timelines and quality.

Ensured accurate and consistent coding of medical history, drugs and adverse event terms using MedDRA and WHODD coding. Support Computer System Validation Projects and Equipment Qualifications which support Lab Operations.

Contributed to the preparation of root cause analysis and investigation of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines.

Initiate corrective and preventive action (CAPA) measures following review of root cause analysis with senior drug safety personnel.

Performed QC on peers within the organization to ensure that better standards are achieved.

Provide CSV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards.

Provide support to lead product safety physician in activities relating to monitoring and management of product’s emerging safety profile.

Helped in the adjudication and analysis of signal detection outputs, quality assurance of synthesized key safety information.

Performed case Prioritization/Triaging based on seriousness of adverse events in accordance with SOP guidelines.

Prepared clinical narratives and independently assigned MedDRA coding to any adverse event

Capturing accurate data of case including book in and overall data entry of all fields on the basis of source documents, assessing the causality, seriousness and listedness/expectedness, coding of patient history, concomitant medications, event and drug terms using authentic documents and writing narrative

Processing adverse event reports from spontaneous sources, clinical trials, studies and marketing activities (including healthcare professionals and consumers) in accordance with company standard operating procedures (SOP) and guidelines for maintaining regulatory compliance.

Recognizing and reporting adverse events using appropriate forms

Requesting additional or follow up information and clarification as necessary with internal and external clients

Maintenance of high compliance standards with respect to reporting timeliness (local and global)

Reviewing patient information in database and ensure accurate documentation (paper and electronic) as per client needs

Experienced in collecting safety data from patient support programs

Performing reconciliations of event reports

Reporting deviations and implementing CAPAs

Processing CIOMS received from partners

Maintaining a good working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including- ICH guidelines on safety and efficacy, Volume 9A, FDA guidelines, CIOMS, new EU PV legislation

Drug Safety Associate, Johnson & Johnson Pharmaceuticals, New Brunswick, NJ

Sep 2016-Nov 2017

•Perform quality review for adverse events (AEs), serious adverse events (SAEs)

•Reviewed, triaged, processed and submitted serious and non-serious adverse event reports for spontaneous and sponsored studies, in compliance with global regulations and compliance timelines.

•Utilized medical terminology, MedDRA coding terms and obtained detailed information in prevention of quality assurance discrepancies, review of investigation results, documentation in PQC Management System, investigation and/or closure.

•Effectively met all timelines including coding, AE (Adverse event) processing, AE/expedited AE reporting and Quality control.

•Effectively maintained the safety database (Sceptre) and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process.

•Reviewed Product Quality Complaint (PQC) cases and collaborated with Clinical Research Organization for SAE reconciliation.

•Participated in global regulatory reporting including understanding of reporting and guidelines, successful submission to regulatory authorities; timely completion of cases; remaining current with updated protocols.

•Process adverse event reports received from sites/reporters in Argus safety database and perform QC review of completed individual and periodic safety reports, and submitting these reports to the regulatory authorities.

•Handled and supported in the tracking of cases in excels, allotment, re-allotment of the cases to SPE’s based on priorities and mentoring to new PV staff

•Perform quality oversight of a sample of the cases data entered by utilizing source and mapping documents and adhering to Pharmaceutical SOP's and standards in the Array Migration.

•Processed and reviewed Serious Adverse Events (SAE) to ensure accurate and consistent data entry from source documents (spontaneous, PMS, clinical trials), with emphasis on timelines and quality.

•Ensured accurate and consistent coding of medical history, drugs and adverse event terms using MedDRA and WHODD coding.

•Assist with ensuring that periodic and expedited safety reports comply to both internal and regulatory timelines with strong knowledge of periodic reporting including PADER/DSUR/PSUR/PBRER

•Hands-on expertise in end to end case processing activities (unsolicited, solicited and literature reports) in Pharmacovigilance databases such as Argus and ARISg.

•Employs effective oral and written communication skills to ensure appropriate AE case processing and consistent documentation of medical judgment within the drug safety database.

•Perform reviewing of narratives for medical coherence and also providing comments in accordance with company’s requirements.

•Incorporated benefit-risk information in the report and performed analysis of safety and benefit-risk (SABR) profile of client products.

Education:

B. Tech in Bio Technology

Veltech hightech Dr. RR Dr. SR Engineering College, 2007 - 2011

Certifications:

•FDA’s Post Marketing Drug Safety Surveillance System: FDA

•Accenture Preliminary Certification in Pharma Industry Program

•CCRP-Certified Clinical Research Professional -SOCRA

Skills:

•ICH and GCP guidelines

•Good knowledge of FDA and EU pharmacovigilance regulatory requirements

•Argus/ Sceptre databases

•Demonstrated ability to prioritize and to organize multiple tasks by handling both triage and case processing teams simultaneously

•Proven strong ability in time management, attention to detail, and accuracy

Excellent analytical skills about disease diagnoses, drug-event combinations and drug-drug interaction.

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