Hi, I’m
Shubham Patil
MBA - Healthcare Management
Berlin,Berlin
Summary
Organized and results-oriented PV Specialist & CTA with over 6+ years of experience in Pharmacovigilance working with drugs, medical device. Demonstrated experience in clinical data entry,SMP updating, client communication and PV related activities (Case Processing, Regulatory Submissions). Well verse with Pre-Clinical studies and Post Marketing Studies. Experience in leadership, problem-solving, analytical and teaching skills. Ability to communicate and resolve issues.
Education
International University of Applied Science Berlin
MBA from Healthcare Management
2020.03 - 2021.11 (1 education.year_Label & 8 education.months_Label)
Overview
9
years of professional experience
4
Certificates
Work History
ICON PlcBerlin
Senior Pharmacovigilance Associate
05.2022 - Current
Job overview
- Leading signal detection activities to identify
potential safety concerns by analyzing data from
various sources, such as clinical trials,
post-marketing surveillance, and scientific
literature. - Prepare and submit safety reports to regulatory
agencies as required, submission to investigators
& Ethics committee including PSURs ,DSURs and
risk management plans. - Experience in working with different client and
led multiple studies (5 studies) as Study Lead and
Back-up Lead . - Experience in SMP Creation and Updates, project
over sees by working closely with Project
Managers and serve as safety point of contact. - Managing the pharmacovigilance process,
which involved monitoring, assessing, and
reporting adverse events and safety data
associated with pharmaceutical products. - Evaluation of safety data to assess the risks and
benefits of drugs and medical devices and make
recommendations for risk minimization strategies. - Ensuring of compliance with national and
international regulatory requirements related to
drug safety, including FDA (U.S.), EMA (EU), and
other regulatory authorities. - Generation of Compliance report and proper
execution of action related to KPIs, QEs and
CAPAs. - Utilizing pharmacovigilance databases and
analytical tools to perform in-depth safety data
analysis and generate periodic safety reports. - Supervising and mentoring junior
pharmacovigilance staff, providing guidance
and training to ensure high-quality safety
reporting and compliance. - Collaborated with cross-functional teams,
including medical affairs, clinical development,
regulatory affairs, and quality assurance, to
ensure safety information is integrated into
decision-making processes.
Tata Consultancy ServicesMumbai, MAHARASHTRA
Pharmacovigilance Specialist
09.2017 - 10.2019
Job overview
- Handled Updation and Maintenance of Standard
Operating Procedures (SOP), Pharmacovigilance
Database, Study report, Working Protocol - Trained the team for database and process
training and ensured to have quality data in
Argus Safety Data Base and also anticipated in
internal and external audits - Liaised with clients to get a clear understanding
of Project needs like project improvement plans,
Study timeline, weekly project, and quality
meetings - Supported Project development activities like
Roistering, Workflow management Plan, Task
Distribution, Moments of meeting (MOM),
performing CAPA session - Prepared and maintained QC checklist material
and Processed Clinical trial documents like ICSR,
EudraVigilance (EV Web), CIOMS, Electronic
Safety Data Document (E2B), NIS, IS, Study and
spontaneous report, Line listing, MedWatch - Communicated with Clients (Germany, Brazil, US,
Hungary) for Updating of Study Documents,
Product and label,Quality and team updates
(Biweekly)
Tata consultancy servicesMumbai, MAHARASHTRA
Drug Safety Associate
03.2016 - 08.2017
Job overview
- Maintained the database of incoming Serious
Adverse Event-Reports and Product Technical
Complaint reports for Drugs and medical devices
on PV Global Database (Argus Database) - Performed Case Receipt and triage and Central
case Processing for TA like Oncology, Speciality
Medicine, Consumer Health, Cardiovascular
Medicine and Women Healthcare. - Proficient with Using Medical
Dictionary(MedDRA),and following client's user
manual, SOPs, and regulatory timelines to ensure
accuracy and patient confidentiality - Excellent working knowledge of MedDRA and WHODRUG
coding dictionaries and following User Manual,
SOPs and Regulatory timelines - Coordinated meetings with healthcare team and
prepared meeting agendas to ensure quality
operations - Managed various Clinical Documents types like
Interventional/Observational Studies,
Spontaneous reports, Social Media cases, Case
from literature reviews
Skills
Increased department accuracy through rigorous quality control checks on ICSR entries prior to submission, minimizing the potential for errors or discrepancies
Conducted comprehensive literature reviews for signal detection purposes, helping identify potential risks associated with marketed products
Served as a trusted resource for colleagues seeking guidance on complex case evaluations or regulatory requirements, sharing expertise and promoting a culture of continuous learning
Improved data quality for regulatory submissions by conducting thorough case assessments in compliance with FDA guidelines
Certification
Good Clinical Practice (By Clinical Development Services)