SNEHA BAMBRATKAR
Operations/safety specialist
Summary
Pharmaceutical professional with a strong background in drug safety and regulatory compliance. Skilled in pharmacovigilance, adverse event reporting, and risk management. Known for fostering team collaboration and delivering consistent, high-quality results. Adaptable, reliable, and focused on maintaining patient safety and regulatory standards. Experienced with pharmacovigilance processes and adverse event reporting, ensuring regulatory compliance and patient safety. Utilizes strong analytical skills and a detail-oriented approach to identify and mitigate potential drug risks effectively. Possesses knowledge of industry regulations and risk management practices, contributing to safer pharmaceutical outcomes. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on additional responsibilities to meet team goals.
Overview
6
6
years of professional experience
2
2
Languages
Work History
Operations Specialist
IQVIA
01.2021 - Current
- Company Overview: Working as Safety/Operations specialist at IQVIA in Lifecycle safety department in the area of Biologic (Immunotherapy, Vaccines)
- Oversaw day-to-day operations, delegating tasks appropriately to ensure smooth workflow and timely completion of projects.
- Provided training for new hires, fostering a supportive learning environment conducive to success in their roles.
- Analyzed data to identify trends and make informed decisions, driving continuous improvement in operations.
- Boosted customer satisfaction, addressing client concerns in a timely and professional manner.
- Enhanced team productivity with effective communication strategies and regular performance reviews.
- Facilitated team meetings to encourage collaboration and share best practices across organization.
- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
- To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events (AE)/endpoint information.
- Determining initial/update status of incoming events. Database entry.
- Coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
- Supported audit procedures to check all procedures, processes and work standards.
- Enhanced drug safety by analyzing adverse event reports and identifying potential risks.
- Provided training for new pharmacovigilance team members, fostering a culture of continuous learning and improvement.
- Oversaw adverse events case reporting and conducted follow-up.
- Read scientific literature and bibliographic sources.
- Provided subject matter expertise to support the development of training materials, standard operating procedures, and work instructions within the department.
- Coordinated closely with medical affairs teams to ensure accurate reporting of product-related adverse events from post-marketing studies and spontaneous reports.
- Collected and analyzed data to measure effectiveness of quality control processes.
- Collaborated across departments to identify opportunities for process improvements and increased efficiency.
Clinical Research Coordinator
Getwell Hospital & Research Institute
11.2019 - 12.2020
- Clinical Trial Operations adhere with GCP
- Conduct patients visit as per study trial requirements
- Performed required lab test and sample dispatching to centralize Lab
- Ethics committee approval and regulatory submissions as per sponsors guidelines
- Ethical and Participant Safety Importance
- Study and Site Management
- Informed Consent process in accordance with ICH-GCP
- Data collection
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Gathered, processed, and shipped lab specimens.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
Skilled Project Assistant
ICAR-CICR
10.2018 - 10.2019
- Worked under the project titled as BT Cotton Testing
- Provided assistance with preparation of project-related reports, manuscripts and presentations
- Maintained a well-organized document repository for easy access to vital information during the lifecycle of projects.
- Assisted project managers in achieving timely completion of projects through diligent monitoring and tracking of deadlines.
- Monitored and reported on project risks and proposed solutions.
Education
Master of Science - Biochemistry
Hislop College
Nagpur, India 04.2001 - 2018.01
Bachelor of Science - Biotechnology
Dr. Ambedkar College
Nagpur, India 04.2001 - 2016.01
Skills
Adverse event reporting
Accomplishments
- Grabbed rank 1 and best performer of the month title for achieving maximum productivity and 100% quality data reporting.
- Awarded 4 times for IQVIA IMPACT PROGRAM with ovation and spotlight category.
- Awarded for Best performance in Post Graduate Diploma in Clinical Research and Pharmacovigilance.
- Awarded at Bio Era Life Sciences Pvt. Ltd. Research and Development Center.
Clinical Trial Experience
Emergency Use Authorization program, COVID-19, Biologic (Immunotherapy, Vaccine), Operations Specialist 1, Emergency Use Authorization program., Review and process data from various sources: perform data entry, coding relevant medical terminology, and writing descript narratives.
Therapeutic experience
- Infectious Disease, 4.0
- COVID-19, 4.0, Review and process data from various sources: perform data entry, coding relevant medical terminology, and writing descript narratives.
Personal Information
- Date of Birth: 03/22/95
- Gender: Female
- Nationality: Indian
Training
- Argus version 8.4 training completed.
- Attended Seminar and Hands on Training Workshop on Explore and Understand DNA at BioEra Life Sciences Pvt. Ltd. Research and Development Center, Pune.
- Attended International Conference on Emerging Microbes and Infection and its impact Public Health Organized by Central India Institute of Medical Sciences (CIIMS) at Nagpur.
Areas Of Interest
- Pharmacovigilance
- Drug Safety Specialist
- Clinical Research
- Biotechnology
- Biochemistry
- ICSR case processing
- Post marketing safety
- Clinical Operations
- Quality review
Timeline
Operations Specialist
IQVIA
01.2021 - Current
Clinical Research Coordinator
Getwell Hospital & Research Institute
11.2019 - 12.2020
Skilled Project Assistant
ICAR-CICR
10.2018 - 10.2019
Master of Science - Biochemistry
Hislop College
04.2001 - 2018.01
Bachelor of Science - Biotechnology
Dr. Ambedkar College
04.2001 - 2016.01
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