Nishrutha Karthik

**** ***** **** *****

JACKSONVILLE, FL

203-***-****

ad2g73@r.postjobfree.com

Professional Summary:

Healthcare professional Over 6.5 years of experience in Pharmacovigilance which includes processing of spontaneous, clinical, SUSAR, literature cases and review, clinical narrative writing, quality review, and development and implementation of Global regulations/guidelines, Standard Operating Procedures (SOPs), and training materials.

Hands on experience on ARGUS and ARISg data bases.

Performed vendor management activities like; participating in team meetings with offshore team for query management.

Experience in the processing of SUSAR cases, including identification of cases that need SUSAR reporting criteria, preparation SUSAR narrative, and making the expedited safety report available for distribution.

Triaged every report to confirm the validity of the case and decide on the timelines in accordance with the regulatory requirements for submission and company specific standard operating procedures.

Understanding of global regulatory requirements for Pharmacovigilance.

Proficient in coding standards for serious and non-serious adverse events using MedDRA terminology and drug coding in accordance with WHO-DD.

Medical case review for all ICSRs reported from any source including clinical trials, literature, post marketing studies and post marketing spontaneous adverse event reports in Oncology field.

Provides company causality assessment utilizing clinical and global introspection methodologies aligned with global regulations

Experience with Aggregate reports – Authors the safety sections in DSUR, PSUR / PBRER reports.

Experience with Signal detection (Empirica) - Generated line listings.

Facilitates signal management processes for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with the Medical Director, GDSP, evaluates safety data and signals as part of ongoing pharmacovigilance activities.

Experience with Causality assessment and Medical review of ICSR cases.

Timely reporting of SAEs/AEs to the Regulatory Authorities, and cross-reporting to pharmaceutical partners.

Handling, managing and processing ICSRs from various sources or E2B files received via electronic data exchange (EDC) system.

Expert in generating and updating narratives ensuring quality, clarity and consistency according to CIOMS template and Company’s Standard Operating Procedures (SOP’s) as applicable

Understanding the principles and concepts associated with Patient Safety case-handling process, including regulatory reporting requirements for single case expedited reporting and periodic updates

Literature case reviews and coding which included medical journals abstracts, poster presentation, full literature articles

Handled Quality Assurance functions (process deviations, conducting investigations, assigning / monitoring Corrective Actions and Preventative Actions (CAPAs)) in specific, identified potential problems within pharmacovigilance with regards to possible late case.

Performed database searches, generate and analyze reports to make sure all appropriate cases are pulled in the report as per the regulatory requirements.

Experience in quality review of line listings and verify number of cases and reports.

Monitored workflow status of adverse event reports in the drug safety data base to ensure compliance with case processing and validation.

Reviewed all medical and drug terminologies according to project specific coding conventions, Investigator Brochure (IB) and Company core data Sheet (CCDS).

Hands on experience with Serious Adverse events (SAE) Reconciliation.

Experience in identifying areas for improvement and deviations from processes.

Hands on experience in creating SOP development/amendments and help for documents within clinical trial including, safety management plan and for data management plans.

Hands on experience in workflow monitoring (WF) and quality review (QC) activities.

Possesses the important feature of Quality and thoroughness as cases submitted to health authorities.

Knowledge of ICH, GCP Guidelines; FDA, EU regulations and high awareness of global nature of drug safety.

Education:

MBBS (Bachelor of Medicine & Bachelor of Surgery) - PSG Institute of Medical Sciences & Research, Coimbatore, Tamil Nadu, India – 2014.

Experience Summary:

UBC, PA

Safety Physician Sep 2022- Present

Responsibilities:

Medically review and evaluate ICSRs for all company products either marketed or in clinical development in ARGUS database.

Medical case review for all ICSRs reported from any source including clinical trials, literature, post marketing studies and post marketing spontaneous adverse event reports in Oncology field.

Provides company causality assessment utilizing clinical and global introspection methodologies aligned with global regulations

Assess AE and SAE expectedness for each event per Reference Safety Information (RSI) and ensure correct, consistent interpretation and application to ICSRs Review case narrative and medical contents for completeness, identify missing medical information or key data that impact medical understanding and evaluation of the case, and issue safety medical queries

Generate line listings for aggregate reports: DSUR and PSUR.

Authors the safety sections in DSUR, PSUR / PBRER reports.

Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable.

Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines.

Support PV Management by attending a variety of meeting forums, including but not limited to Pharmacovigilance Operation meetings, cross-functional meetings, Pharmacovigilance Service Provider (CROs) operational meetings and Business Partners team meetings.

JAZZ, CA Oct 2019 – Aug 2022

Medical Reviewer

Responsibilities:

Provided Medical review and company causality assessment for all ICSR cases.

Medical safety monitoring of trials and ensure the patients safety, evaluation and assessment of serious adverse event reports. Signal detection and medical review of coding. Primary medical reviewer of individual serious and non-serious adverse event reports from clinical trials and post-marketing safety surveillance, review of case narratives and safety narrative plans.

Review and approve Analysis of Similar Events and provide company comments and assessment with medical analysis for SUSAR Reports

Identify important/critical cases with potential safety signals at single case level (i.e. first line signal detection), escalating Product Safety Lead Physician/Safety Scientist and Medical Monitors, and upper management as necessary

Issue urgent medical queries on urgent follow-ups, coordinating with Product Safety Lead Physician and Medical Monitors as required.

Review of Aggregate reports: Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs/PADER)/ Periodic Benefit Risk Evaluation Reports (PBRERs), MedDRA and WHO Drug dictionary coding. Literature Review

Labeling assessment to establish expectedness /relatedness. Evaluates cases for seriousness, relatedness, and expectedness according to the protocol, investigator brochure, and/or package insert.

Worked on Risk Management Plan (RMP).

Assist with response to safety-related queries from regulatory authorities or Ethics Committees, if needed.

Monitor and manage the ICSR workflow for assigned projects and products to ensure all deadlines are met and compliant with safety reporting obligations in accordance with international reporting regulations, SOPs and safety processing guidelines as defined by department management.

Support PV management in investigation, root cause, corrective and preventive actions related to internal and external PV associated CAPA findings

Support PV Management by attending a variety of meeting forums, including but not limited to Pharmacovigilance Operation meetings, cross-functional meetings, Pharmacovigilance Service Provider (CROs) operational meetings and Business Partners team meetings as required. Participate in the training activities related to ICSR case handling.

Worked with the Safety Review team lead/Manager to escalate issues or tasks outside the normal scope of work.

TCS, NJ Feb 2018 - Oct 2019

Safety Specialist

Responsibilities:

Performed triage on all case types and determined labeling and case assessment to determine prioritization, performing duplicate case searches and enter basic case data.

Received and entered adverse drug events, as well as follow-up from vendors, clinical trials, and spontaneous complaints from consumers and healthcare providers into ARGUS.

Managed data from both post market as well as clinical trials according to specific regulations and guidelines.

Perform accurate data entry of identified adverse event information onto the company validated received from various sources. This includes clinical trial reports, spontaneous, medical device, regulatory and literature reports.

Responsible for initial triaging of cases coming from the US drug safety intake.

Reviewed, ranked, verified, processed, and documented case-related information: event terms, validity, seriousness, special scenarios, timeline accuracy and consistency effectively using both MedDRA coding as well as WHO-DD to report necessary items.

Reconciled with all internal and external reporters accurately and promptly.

Proficiently wrote and, where necessary edited the case narratives of each adverse drug event received.

Identify adverse events, seriousness, and listedness / labeledness for case completion.

Identify potential product complaints to forward to that function and perform all appropriate coding.

Serve as mentor for newly hired colleagues/contractors, providing detailed training regarding the assessment of all case types; assess progress and provide feedback to management.

Perform own QC of reports and perform reconciliation of clinical Serious Adverse Events.

Takeda, MA Nov 2016 - Feb 2018

Drug Safety coordinator

Responsibilities:

Performed Triage, Data Entry of adverse event reports from Spontaneous, Marketing, Literature, Non-Interventional and Clinical trial cases using ARISg.

Completed case narratives and performed medical coding of the data using CDD, WHO-DD and MedDRA.

Reviewed adverse event information received for completeness and consistency, initiated case follow-up activities/AE query management, and independently generated narratives in accordance with department processes.

Conducted training sessions regarding conventions and different case scenarios.

Assisted in developing and maintaining standard operating procedures and guidelines for Drug Safety operations.

Ensured compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and Pharmacovigilance reporting requirements.

Participated /attended clinical team meetings when appropriate and provided technical advice and support to the clinical team.

Served as back-up, when needed, for other Drug Safety Associate colleagues.

Contributed to FDA inspection readiness planning.

Participated in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures.

Adhered to company templates and guidelines for documentation and communications.

Ensure compliance with corporate and departmental standard operating procedures.

Ganga Multispecialty hospital, Coimbatore, India – Consulting physician Aug 2014 - Jul 2016

●Supervised and provided systematic care to patients in Neurology and Neurosurgery wards as well as in outpatient clinics, admitted the patient’s needing investigations, special care, and treatment

●Prescribed medicines and carried out surgical procedures

●Liaised with other non-medical and medical faculty to guarantee high quality treatment

●Participated actively in the orientation programs of new faculty to organization’s policy, philosophy, health center functions, and procedures to encourage effective teamwork.

Residential Internship - PSG Institute of Medical Sciences and Research Jun 2013- Jun 2014

●Appropriately diagnosed and treated a variety of diseases and injuries as a General Practitioner in Outpatient as well as Inpatient settings.

●Managed caseload of 30-40 inpatients, providing health education, treatments, IV therapy, venipuncture, wound care, and other clinical procedures.

●Managed, directed, and coordinated activities of nurses, assistants, and other medical staff.

●Monitored patients' condition and progress and re-evaluated treatments, as necessary.

●Assisted in major surgeries, performed minor OT procedures.

●Presented seminars educating fellow colleagues and community in promoting health

●Academic/Research Project : On Incidence and Prevalence of Notifiable Diseases.

●Ensuring that laboratory and other investigations are ordered and carried out and the results are collected and appropriately documented.

● Writing discharge summaries which, was countersigned by residents or attending physicians.

●Interviewed new patients to obtain history, examination to form a diagnosis Carried out medical and surgical procedures Counseled patients on disease conditions.

Publications:

Karthik N, Gnanapandithan K. Cocaine Use and Splenic Rupture: A Rare Yet Serious Association. Clinics and Practice. 2016, Aug; 6(868): 65-67.

Gnanapandithan K, Karthik N, Muniraj T. Pancreatic Tail Neoplasm Masquerading as

Recurrent Splenic Abscesses. J Gastrointest Cancer. 2017 Mar 28.

Gnanapandithan K, Karthik N, Singh A. Rhabdomyolysis and Acute Kidney Injury Associated

with Anabolic Steroid Use. Am J Med. 2019 Aug;132(8):e652-e653

Gnanapandithan K, Karthik N, Gerber J. Methadone, Metoclopramide and Metronidazole Interaction

Causing Torsades de Pointes. Clinics and Practice. 2021 Feb 7;11(1):101-105.

Medical student research experience:

Jan 2012- Dec 2012 Medical Student Research

Preventive Medicine

PSG Institute of Medical Sciences and Research

Coimbatore, Tamilnadu

May 2012-Jun 2014 Medical Student Research

Medicine

PSG Institute of Medical Sciences and Research

Coimbatore, Tamilnadu

Computer experience:

●Safety databases (ARGUS, Aris-g)

●MS Office (Word, Excel, PowerPoint, Outlook, OneNote, TEAMS, Nitro, PDF)

●CTMS, eTMF (Veeva Vault)

●EDC (OC-RDC, Rave, inform, Omnicomm-TrialMaster)

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