Vaibhav Gharat
Thane
Summary
Accomplished Pharmacovigilance Professional specializing in signal detection and safety evaluations, recognized for strategic leadership in managing cross-functional teams and external service providers. Proven track record of developing innovative safety signal management strategies while ensuring compliance with industry standards and regulatory requirements. Meticulous attention to detail and extensive knowledge of safety regulations across multiple industries drive consistent compliance and operational excellence.
Overview
18
18
years of professional experience
Work History
Associate Medical Safety Director
IQVIA RDS LTD
Thane
09.2022 - Current
- Aggregate reviews of safety information, including clinical trial data and Clinical Safety Reports (CSRs), to maintain product safety oversight
- Review pharmacovigilance data for new safety information and signals
- Signal detection and analysis for nearly 20 signals, and prepared responses to health authorities, ethics committees, IRBs, and external partners
- Examined product safety alerts and implemented proactive safety analysis strategies
- Document, coordinate, review, and validate periodic reports (RMP, DSUR, PSUR, PBRER, HHE, SBR analysis, Post Marketing Safety Surveillance)
- Participated in Safety Management Committee (SMC), Safety Management Team (SMT) meetings, LWG, and LRC
- Provided inputs for audit-related activities for internal and external partners
- A leading global provider of advanced analytics, technology solutions, and contract research services
Manager - Medical Review
APCER Life Sciences Pvt Ltd
Delhi
06.2017 - 09.2022
- Managed a team of 10 physicians, assigning roles and responsibilities, facilitating regular meetings, and providing mentorship and support
- Conducted comprehensive training sessions on signal detection, case assessment, and report writing, resulting in 100% achievement of the target quality SLA and improved case quality through continuous education
- Implemented project management tools to manage timelines and ensure timely completion of tasks
- Performed data analysis, collaborative review, and thorough documentation of signal detection processes, validating potential signals and conducting regular review meetings meeting SLA criteria
- Prepared and reviewed safety reports like PBRERs, PADERs, and drug safety reports, implementing a peer review process to ensure report quality
- Executed comprehensive reviews of individual case safety reports on ARGUS and ArisG
- Wrote and updated SOPs to reflect current practices and regulatory requirements
- A global provider of pharmacovigilance and drug safety services
Assistant Project Manager
Bioclinica Ltd (Formerly Synowledge Ltd)
Mysuru
09.2016 - 05.2017
- Assessed case reports for over 500 ICSRs from various sources for oncology products and biosimilars
- Determined regulatory reportability of cases within the therapeutic team
- Achieved triage of over 500 cases for seriousness and relatedness
- Verified appropriate selection of adverse events from source documents and assigned MedDRA codes
- A global clinical trial services provider
Manager - Medical Reviewer
Lupin Ltd
Mumbai
02.2014 - 09.2016
- Supervised a literature search team and managed the workflow of the ICSR team to meet regulatory timelines
- Conducted medical reviews of over 2000 ICSR cases
- Completed medical reviews of periodic reports for over 50 reports
- Handled medical inquiries and led audits for the literature team with 0 findings
- Authored standard operating procedures (SOPs)
- A multinational pharmaceutical company
Medical Reviewer, Drug Safety and Epidemiology
Cognizant Technology Solutions
Mumbai
07.2012 - 02.2014
- Conducted medical reviews for over 1000 ICSRs and ensured timely case processing
- Mentored new medical reviewers and provided feedback to case processors
- A multinational technology company providing IT services
Programme Officer - STI
Avert Society (USAID Funded)
Mumbai
06.2011 - 06.2012
- Oversaw STI control in Maharashtra, providing training and ensuring timely reporting
- Coordinated with NRHM officials and explored EQAS for test monitoring
- A non-profit organization focused on health initiatives
Surveillance Medical Officer
World Health Organization (NPSP)
Bihar
07.2010 - 03.2011
- Led Polio control efforts, providing training and logistical support
- Organized meetings with stakeholders and improved surveillance coverage
- A specialized agency of the United Nations responsible for international public health
Resident Medical Officer
B.Y.L. Nair Hospital
Mumbai
06.2008 - 04.2010
- Provided patient care in outpatient and inpatient settings
- Conducted community outreach for public health initiatives
- A public hospital offering various healthcare services
Medical Intern
Pad Dr. D. Y. Patil Medical Hospital
Navi Mumbai
02.2007 - 02.2008
- Internship in various departments at medical hospital
- A medical facility for practical training of medical students
Education
Post Graduate Diploma - Public Health
T.N.Medical College
Mumbai04.2010
M.B.B.S - MD
Pad Dr. D.Y.Patil Medical College
Mumbai12.2006
Skills
- Drug Safety Regulations Knowledge
- Signal detection analysis
- Post-marketing surveillance
- Risk management planning
- Medical literature review
- Pharmacoepidemiology Research Skills
- Argus Medical Review Signal
- MS Office
- PowerBI
- Project Management Tools
- Real-World Evidence Expertise
- Standard Operating Procedures
- Team Leadership
- Pharmacovigilance auditing
Timeline
Associate Medical Safety Director
IQVIA RDS LTD
09.2022 - Current
Manager - Medical Review
APCER Life Sciences Pvt Ltd
06.2017 - 09.2022
Assistant Project Manager
Bioclinica Ltd (Formerly Synowledge Ltd)
09.2016 - 05.2017
Manager - Medical Reviewer
Lupin Ltd
02.2014 - 09.2016
Medical Reviewer, Drug Safety and Epidemiology
Cognizant Technology Solutions
07.2012 - 02.2014
Programme Officer - STI
Avert Society (USAID Funded)
06.2011 - 06.2012
Surveillance Medical Officer
World Health Organization (NPSP)
07.2010 - 03.2011
Resident Medical Officer
B.Y.L. Nair Hospital
06.2008 - 04.2010
Medical Intern
Pad Dr. D. Y. Patil Medical Hospital
02.2007 - 02.2008
Post Graduate Diploma - Public Health
T.N.Medical College
M.B.B.S - MD
Pad Dr. D.Y.Patil Medical College