Professional Highlights:

I am a physician (MD/ ECFMG certified) with 5 years of clinical experience and diverse experience in the industry. I possess both CRO and pharmaceutical company experience and currently seeking an opportunity to transfer skills and to advance up in the field.

CORE COMPETIENCIES:

Phase I to IV: Medical monitoring support by reviewing CRFs and safety data review.

Reviewing and reporting deviation and violations

Processing and QC ICSR from clinical trials and post marketed (Phase I to IV)

Preparing and reviewing the data listings

Reconciliation between safety and clinical databases

Broad knowledge of FDA, GCP, ICH, US and EU- PV regulations

MedDRA, WHODD, and WHOART

Database- ARGUS, SCEPTRE, Medidata RAVE, EDC

Computer skills: Microsoft Word, Excel, PowerPoint

Bachelor of Medicine and Bachelor of Surgery (M.B.B.S) - Bangalore University, India

Diplomate Of National Board (OB-GYN)- New Delhi, India

Experience:

Senior safety scientist May 2016 to Jan 2017

INC Research Inc., Raleigh, NC

Recognized daily workload and assisted with the workload based on priority

Responsible for running twice daily reports and updating the AE tracker

Coordinated with the safety team and other teams (Medical monitors/reviewer) to ensure submission within the timeline

Liaised with Manager/designee with regard to resources, timelines, and issues with quality

Managed AE tracking systems from receipt to reporting of adverse events (AE)

Triaged and Processed both serious and non-serious ICSRs, AESI within the timeline

Processed AEs from various sources from both global clinical trial and post marketed

Performed QC of the entered data in the safety database

Performed query creation and interacted with study site personnel until resolution

Reviewed regulatory reports and authored SDEA and safety sections of SMP

Performed reconciliation of database, reviewed tables and listings

Assisted with data retrieval, line listing and preparation for Safety reports

Senior Safety Scientist/Safety monitor/Shared Pharmacovigilance Nov 2015 – May 2016

Telerx-PA

Involved in complete SAE/AE case processing lifecycle, QC, reconciliation of data between the databases

Performed Triage, DE, case processing, high quality narrative generation, QC, reporting

Handled cases from various sources- (consumers, healthcare professionals and investigators)

Performed data review and evaluated for coding consistency

Proficient in processing both clinical trial and post marketing AE reports

Supported regulatory document preparation – reviewing ICSR, line listing request, review of aggregate data

Actively engaged in gap analysis for SOPs and guidance documents

Contributed for preparation of safety aggregate reports

Performed literature review for identification of case reports and other relevant safety information

Collaborated with Senior Management to update or design project process improvements

Liaised with both internal and external vendors (client, patients and HCPs)

Served as the case processing “expert” at the client level

Achieved specific project milestones and standards, which included volume, timelines and data quality

Partnered with Program Manager in communicating key issues and milestones

Drug Safety Associate April 2015- September 2015

Johnson &Johnson- PA

Actively involved with Triaging, classify ICSR and prioritizing according to regulatory reporting.

and processed diverse AEs - serious and non-serious AE reports (Phase I-IV) and post marketed products

Authored high quality narratives and edited auto-narratives

Consistently followed data entry convention using MedDRA, WHODD, WHOART

Reviewed and edited information (label, approval, manual coding etc.) as per the DE convention

Performed duplicate checks, merger and deletions, single-case un-blinding etc.

Supported identification of corrections and creation of updates in the safety DB

Generated queries, created targeted follow-up letters until query resolution

Liaised clinical team representatives to resolve discrepancies, query follow up

Supported confirmation of case registration/committal information by Global Case Receipt staff or other designee (e.g. Authorized LSO)

Maintained good knowledge and understanding of all the project specific SOPs

Involved in identifying and tracking the serious and non-serious AEs, AESI

Maintained continuous knowledge and expertise in local and global requirements for safety reporting.

Completed all assigned training on company and GMS procedural documents relating to case processing.

Areas of responsibility included Biologics, Cardiovascular, and Anti-Infective, immunotherapy, skin, bones and Oncology.

Independent Evaluator April 2014 – April 2015

Veterans Affairs Medical Center- Washington, DC

Supported medical monitor in reviewing patient profile, case report forms, subject’s clinical data review, lab reports in clinical database

Actively involved in identifying safety deviations and reporting the sponsor

Supported the team in determining if the subject may/not continue in the study

Collaboration with various clinical teams and other extended team on various activities (safety, data management and regulatory affairs)

Provided medical and scientific support for project management teams

Served as a medical resource to investigational teams on safety issues, AE, SAE reporting, dosing of the study drug

Assisted in reviewing the compiled data as part of safety signal detection

Liaised with the sponsors on SAEs and deviations

Areas of responsibilities included Psychiatry, Hematology, Pain and Oncology

Drug Safety Specialist Feb 2010 – Jan 2012

Novartis Consumer Health – NJ

Assessed AE/SAE and processed information from complex documents from both clinical trial and post- marketed

Performed complete case processing from Triage, DE, event ranking, labeling coding, causality assessment, drafted/updated company comments

Performed QC of all cases processed by other team members and updated the QC tracker

Created, reviewed, updated and generated follow-up letters as appropriate

Updated adverse event reports within ARGUS to support line listings.

Participated in product meetings within the drug safety department.

Lead projects as delegated by senior staff members.

Supported Triage conducted by Senior Specialist as needed.

Received phone calls and completed telephone reports

Certifications:

2009 - US ECFMG Certified

2010 - IRB Research Certification

2010 - HIPAA Certificate

2011 - DIA Pharmacovigilance Certificate

2012 - MedDRA Certification-MSS0

2014 - VA Human Subjects Protection and Good Clinical Practice

2014 - VA ORD Biosecurity Training

2014 - Privacy and HIPAA Focused Training

2014 - VA Privacy and Information Security Awareness and Rules of Behavior

2017- American Medical Writers Association- Essential skill certification

Education:

Bachelor of Medicine and Bachelor of Surgery (M.B.B.S.)- Bangalore University, India

Diplomate of national board (Residency training completed and board eligible)

Professional affiliations/Membership:

American Medical Writers Association: (2016- Present)

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