Drug Safety Specialist
Resume:
Naveen Kumar
******.************@*****.***
OBJECTIVE:
Daily target 15-17 Case Processing
To obtain a challenging position as Drug Safety Associate and launch a successful career that will promote my growth and experience in safety field, to enhance the patient’s safety. Experienced in performing Triage, Data entry, MedDRA coding, narrative writing for submission of individual case safety reports.
EXECUTIVE SUMMARY:
Over 3 plus years of drug safety experience in handling Clinical trial and post marketed individual Case Safety Reports (ICSR).
Experience in processing clinical trial and post marketing adverse reports.
Maintain a high level of vigilance to clearly identify cases that require high priority processing to prompt reporting of serious adverse events in accordance with company SOPs, FDA, ICH and global regulations.
Experienced in case processing including data entry and writing descriptive narratives.
Experience in daily activities including triage cases, accurately encoding them into safety database, writing an accurate and concise narrative.
Experience in defining and appraising patient medical history, critical event information from reporting sources including follow-up information from the investigational sites to complete a good quality case narrative in compliance with company standard operating procedures as applicable.
Worked with Regulatory submissions team for accurate and on time submission of expedited safety reports (SUSARS) and annual safety reports.
Experienced in performing Quality check on ICSR’s and aggregate reports including PSUR’s and PBRERs for accuracy and consistency.
Experienced in generation of safety queries for appropriate case information for clinical study cases.
Proficient in data entry and excellent knowledge of ARGUS safety and ARISg safety databases.
Proficient in monitoring and tracking adverse events (AE's), serious adverse events (SAE's), other medically significant data and excellent record keeping and follow through on events at all levels.
Well-coordinated in the submission and distribution of expedited and non- expedited safety reports to regulatory authorities.
Excellent command on medical terminology and expertise in utilization of MedDRA for coding adverse events and drug information in accordance with WHO-DD.
Excellent knowledge in FDA and ICH guidelines.
Excellent knowledge of IND safety reports and PSURs reporting guidelines.
Submission of product complaints and technical complaints to product monitoring and Quality Assurance team respectively.
Specialized in Ad hoc or customized literature searches.
Well-coordinated with the in-house physician, nurses for clarification and effectively communicated with the hospital call centers for drug related information.
PROFESSIONAL EXPERINCE:
PPD, Morrisville, NC
Drug Safety Specialist Mar 2016 - Aug 2016
Responsibilities:
Day-to-day responsibility includes data entry and maintenance of databases.
Case Processing includes collection, monitoring, assessment, evaluation, research and tracking of a safety information.
Coordinate and perform adverse event data entry, coding and assessment of adverse events, case review, follow-up with reporter and/or associated HCP, tracking of reports, writing narratives according to client request and regulatory reporting activities within PPD owned and client provided adverse event database .
Review literature articles and process adverse event reports from literature per project and FDA guideline.
Determine follow up requirements and perform follow up for all case types.
Responsible for ensuring that submission records are maintained in the safety database.
Process and review safety narratives for adverse event cases as required .
Performing quality review and checking cases for discrepancies for any errors related to labeling and narrative writing .
Performed quality check of adverse event reports for seriousness, causality and expectedness, Expedited safety reports.
Performed adverse event reporting and subsequent Pharmacovigilance (PVG) activities within a highly regulated environment and driven by strict timelines .
Actively participate in weekly team meetings and also departmental team meetings and trainings as necessary and audits as required.
Reviewed processed cases to verify accuracy, consistency and compliance with process requirements and determine if appropriate case follow-up has been considered.
Assigned resources and timeliness, reorganizes daily workload based on priority.
Performed screened submission of E2B report for failed and pending reports. Re-transmitted report as appropriate. Environment: ARISg.
GVK Biosciences
Drug Safety Associate Feb 2013 -Dec 2014
Responsibilities:
Receiving, reviewing, processing and follow up of AEs and (SAEs) reports.ds
Triage of incoming cases to determine validness and seriousness for prioritization of daily workflow.
Responsible for Drug Safety contribution to Periodic Safety Update Reports and SAE management plan.
Data collection and entry of AEs/SAEs received from clinical trials in a timely fashion to ensure compliance with local and global regulatory reporting.
Perform data entry using ARGUS safety database from source document.
Processing each and every case individually, by assessing the safety issues and prioritizing them accordingly before submitting to FDA.
Writing of narratives for each safety report that is processed, and generates follow-up requests appropriately as needed.
MedDRA coding of adverse events and Medical History accurate assessment of reporting requirements in terms of expectedness.
Given special responsibilities to handle cases which are SUSAR and which needs expedited reporting.
Performed accurate follow-ups with HCP’s in timely fashion in order to gather the pertinent information to the case.
Expertise in generation of line listings for submission of PSUR’s and PBRER’s.
Expertise in generating clinical study queries for the fulfillment of individual case safety information.
Worked in overdose cases and handled these special cases carefully along with creating and distributing over dose/Safety letter notifications for all the principle investigators.
Collaborating with other departments to ensure appropriate collection and handling of safety data.
Expertise in performing SAE Reconciliation for accuracy of case specific information in Clinical Trail and Safety Database.
Responsible for understanding and educating the clinical development team on corporate safety processes and provide comments consistent with department guidelines and clinical safety issues.
Worked on QC team for the accuracy and to ensure the quality on processed cases
Working with clinical operations and data management to resolve safety data collection.
Training of new safety staff on database and case processing.
Environment: ARGUS, ARISg, Clinical database- Inform.
NTT DATA
Drug Safety Associate Feb 2012 – Jan 2013
Responsibilities:
Worked in data entry, processing and case closure team.
Coding adverse events and patient medical history with the help of coding standards in MedDRA.
Assumed primary responsibility to collect details of Adverse Events (AEs) and perform initial assessment according to local procedures and in accordance with company global drug safety procedures.
Triaged every report to ensure the validity of the report in a timely manner in accordance with the regulatory/business partner requirements.
Creating of initial reports by directly entering information into drug safety database (ARISg), amending of reports and enter follow up information as acquired.
Handling and reviewing of relevant safety tracking system ARISg for accuracy and quality.
Expertise in generating safety narrative without missing any case specific information.
Documenting and processing of Serious Adverse Events (SAEs), spontaneous reported AEs and other safety and medically related information within company, sponsor regulations and timeframes.
Generating follow up letters and contacting Health Care Professionals (HCPs) for case related specific information.
Supporting the clinical team in monitoring a trial, perform database reconciliation activities, review, investigate, track and report AEs/SAEs in compliance with the global regulatory regulations.
Handling safety issues by managing all the SAEs from initial reporting till case closure.
Creating safety enquiries and communicating with different sites.
Environment: ARGUS
Education:
Masters in Computer Science, USA.
Masters in Life Sciences, UK.
Bachelor of Science in Life Sciences OU, India .
TECHNICAL SKILLS
Efficient in MS DOS, Microsoft word, Excel and Power point.
ENVIRONMENT:ARGUS, ARISg, SAS, MS SQL SERVER, SQL and MS-Office
LICENCE: Registered pharmacist by “Pharmacy Council of India”
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