SUBHA THIKIL VEETIL
Hackensack,NJ
Summary
Organized and result-oriented professional with over 10 years' experience in drug safety/medical domain from concept to development. Extensive Knowledge of FDA regulations, ICH and GCP guidelines. Team player with excellent communication skills and time management abilities.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Manager - Pharmacovgilance Operations
IGM Biosciences
Mountain View, CA
04.2023 - Current
- Implements and monitors compliance with internal procedures, regulatory requirements, and vendor contractual requirements with PV.
- Perform User Acceptance Testing of electronic data capture systems to ensure that the software performs all the required tasks and does not miss collection and reporting of any adverse events.
- Ensures the receipt, assessment, tracking, follow-up, and reporting of SAEs are done on time.
- Works in the Argus database to pull reports, review data, and ensure quality standards are met.
- Reviews adverse event reports, narratives, follow-up requests, and codes adverse events in MedDRA, in conjunction with medical monitors, in preparation for finalization of reports as required.
- Maintains an effective relationship with safety vendors and internal stakeholders to ensure the smooth running of this function and for timely issue resolution.
- Prepares line listings and case narratives for safety reviews, as required.
- Assist with submission of expedited reports to regulatory authorities and clinical investigators.
- Contributes to the timely preparation of ad-hoc and aggregate reports, including DSURs and monthly SUSAR line listing reports.
- Performs review of various essential documents like protocol, safety management plan, case report form guidelines, DSUR, IBs etc.
- Works with the safety vendors to initiate study start-up and closeout activities.
PHARMACOVIGILANCE OPERATIONS CONSULTANT
CCS Associates, Inc.
San Jose, CA
05.2018 - 03.2023
- Processes and tracks initial and follow-up ICSRs to completion
- Data entry and review of ICSRs
- Supports Safety Physicians in medical assessments and query review and escalation
- Provides background information on previous ICSRs to support evaluation by Drug Safety Associate
- Prepares discrepancy reports to be sent to sites, and reviews site's responses
- Manages and communicates effectively with sponsor, pharmaceutical partners, medical monitors, and investigative sites
- Trains staff and tracks requirements for all Safety Data Exchange Agreements (SDEAs) with pharma partners.
- Maintains electronic and hard copy of ICSRs case files
- Prepares AE/SAE reconciliations for sponsor and pharmaceutical partners
- Drafts weekly, biweekly and monthly ICSR reports for the sponsor and pharmaceutical partners
- Trains new hires on case processing, data entry, data review and U.S Food and Drug Administration (FDA) regulations
- Prepares and reviews documents required for IND safety reporting
- Processes and performs initial review of external safety reports
- Prepared detailed internal administrative processes and SOP (Standard Operating Procedures) for in house purposes
- Provides input to the Data management team to improve and create in house databases
- Reviews protocols and updates safety sections as needed
- Assists in compiling and drafting monthly reports for DSMBs and Safety Committees, if applicable per Sponsor
REGULATORY AFFAIRS ASSISTANT
CCS Associates, Inc
San Jose, CA
03.2017 - 05.2018
- Assists with regulatory document review and processing (inputting data, coordinating, tracking, and quality checking, and filing regulatory documents)
- Works with the safety team in entry, processing and tracking of incoming serious adverse events
- Assists with creation and maintenance of regulatory documentation tracking reports
- Assists with processing and tracking protocols and protocol-related documents, maintains electronic copies of protocols and related documents, distributes protocols to in-house staff, and enters protocol data in the the company in-house database
- Works with team members to perform quality check of all case process related activities during audits and inspections
- Manages and traine's the new hires
- Provides professional support to new staff and resolution to any case specific and database queries
CLINICAL RESEARCH COORDINATOR INTERN
Bone Marrow Transplant Group Stanford Cancer Clinical Trial Institute
Stanford, CA
04.2016 - 06.2016
- Documents Preparation - Participant eligibility checklist, patient study calendar, quick study guide, pre-screening log, CRC checklist, physician order
- Reviews the study specific protocol and prepares catalog for smooth daily trail activities
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies
- Data entry - Redcap, OnCore
- Regulatory binder preparation
- Reviews the medical reports of each subject and lists the AE/SAE for easy review by the investigator
- Data retrieval, and clean-up of data generated in the in house database
- Prepares listings of progress of each study on a daily basis to track the progress and for unchallenging evaluation for the investigator
- Adverse event log
CLINICAL INTERN
South Asian Heart Center, El Camino Hospital
Mountain View, CA
12.2015 - 04.2016
- Working with the patients to record their medical, family history, food habits, etc
- Update electronic medical records, test results and correspondence
- Document, verify and validate the research data
- Record their progress and compliance with the program
TRAINEE CLINICAL RESEARCH CO-COORDINATOR
ICBio Clinical Research Pvt Ltd
Bangalore, Karnataka
07.2013 - 01.2014
- Obtaining subject consent and documenting consent process
- Performing study procedures in a detailed and, accurate manner in compliance with protocol and regulatory requirements
- Completing case report forms for Pl review and approval
- Helped maintain study records and assisted CRA in case report form and source document verification
PHYSICIAN
Sitaram Pharmacy's Franchise
Kannur, Kerala
07.2010 - 01.2013
- Owned Sitaram Pharmacy's Franchise in Kannur and worked as a consulting Physician
- Examined up to 20-30 patients per day and assessed their medical conditions and provided proper treatment
- Discussed various treatment options extensively with patients and families
- Worked as a Consultant Physician in R.J Herbals on Weekends
INTERN
Karnataka Ayurveda Medical College and Hospital
Mangalore, Karnataka
03.2009 - 03.2010
- Helped to prepare and maintain patient records
- Worked as an Internee, where I assisted doctors during their patient visits
- Helped take care of patients in absence of the doctor under doctor's instructions
- Worked as a part of the team conducting free health camps in and outside Mangalore
Education
Masters in Hospital Administration -
University of Cincinnati
Cincinnati, OH01-2018
Clinical Trial Design and Management Program -
UCSC Silicon Valley Extension
Santa Clara01-2015
Post Graduate Diploma - Clinical Research And Clinical Data Management
ICBio Clinical Research Pvt Ltd
Bangalore, Karnataka, India01-2014
Bachelor of Ayurveda Medicine and Surgery -
Karnataka Ayurveda Medical College Hospital
Mangalore, Karnataka, India01-2010
Skills
- Practiced inpatient and outpatient caregiver
- Manages and educate new staff in regulatory requirements, GCP compliance, protocol compliance, SOP, case processing and in house databases
- Knowledge of FDA regulations & ICH GCP
- Extensive medical terminology knowledge
- Strong understanding of Clinical trial site trials, monitoring, auditing & inspection
- Strong domain knowledge in the field of Clinical trials
- Good working knowledge of Clinical Trials Data
- Informed consent process
- Ensure accurate coding of all events for serious and non-serious cases with the use of MedDRA (Medical Dictionary for Regulatory Activities)
- Knowledge of Microsoft Word, Microsoft Excel, PowerPoint Presentation, Internet applications
- Regulatory documents preparation
Certification
- NIH Information Security and Management Refresher
- Good Clinical Practices
Memberships
Drug Information Association (2023-present)
Timeline
Manager - Pharmacovgilance Operations
IGM Biosciences
04.2023 - Current
PHARMACOVIGILANCE OPERATIONS CONSULTANT
CCS Associates, Inc.
05.2018 - 03.2023
REGULATORY AFFAIRS ASSISTANT
CCS Associates, Inc
03.2017 - 05.2018
CLINICAL RESEARCH COORDINATOR INTERN
Bone Marrow Transplant Group Stanford Cancer Clinical Trial Institute
04.2016 - 06.2016
CLINICAL INTERN
South Asian Heart Center, El Camino Hospital
12.2015 - 04.2016
TRAINEE CLINICAL RESEARCH CO-COORDINATOR
ICBio Clinical Research Pvt Ltd
07.2013 - 01.2014
PHYSICIAN
Sitaram Pharmacy's Franchise
07.2010 - 01.2013
INTERN
Karnataka Ayurveda Medical College and Hospital
03.2009 - 03.2010
- NIH Information Security and Management Refresher
- Good Clinical Practices
Masters in Hospital Administration -
University of Cincinnati
Clinical Trial Design and Management Program -
UCSC Silicon Valley Extension
Post Graduate Diploma - Clinical Research And Clinical Data Management
ICBio Clinical Research Pvt Ltd
Bachelor of Ayurveda Medicine and Surgery -
Karnataka Ayurveda Medical College Hospital
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