Dr Vignesh Govindarajalu Email & Phone Number

Ahmedabad, Gujarat, India

Authoring and reviewing PSURs for medical devices.Preparation and review of PSUR (PBRER) for medical drugs.Preparation and review of signal reports, signal detection and evaluation.Medical review of ICSRs.

Thane, Maharashtra, India

End-to-end management of PV Safety for multiple APIs (including 20+ antibiotics), providing strategy/ input to other line functions, including local medical officers. Represent safety position in cross functional submission teams and lead cross functional Safety Management Teams (SMTs) Ongoing assessment of the safety status of the product, including Signal Detection and Analysis, and Literature Surveillance Review, preparation, contribution and/or approval of aggregate documents including PBRERs, Signal Assessment Reports, Health Hazard Evaluations, over the counter (OTC) switches Review, preparation, and contribution to questions from Health Authorities, and management of product Safety Alerts

Operations/Management:: Handling Deviations, RCA CAPA, and meeting or exceeding SLAs and KPIs. Responsible for Client/Sponsor relationship Implemented process improvements across many projects resulting in increased metrics, accuracy and internal timelines. Implemented internal career progression pathway (ICSR > APQR > USPR > PSUR > FTE)

Mumbai Area, India

I was in Empirica team in signal detection and was also involved in a pilot project during ths ===.

Mumbai, Maharashtra, India

Managed the aggregate reports team including two PSUR teams along with USPR/PADER and APR/PQR team. Moved into SME role. Currently deputized with the client as part of the Empirica triage team for signal detection activitiesMedical Review and Quality Control (QC) of aggregate reports Experience with PSURs (PBRER) for innovator / originator / biosimilar and generic products as the Lead MR / MR QC reviewer / SME, and Literature review. Handled HA requests for established medicines, as well as medical evaluation of innovator APR/PQR. Experience in drafting Clinical Overview, Signal Evaluation Reports, ADCO, medical evaluation of Product Quality Reports. Literature review to identify and manage signals. Providing domain support for Business Development including RFP/RFI across all PV projects.

Chennai Area, India

Responsible for Medical review of ICSRs and potential identification of signals for cardiovascular (CVS) and oncology (ONC) therapeutic areas, including pre-market phase III monoclonal immunoglobulins (biologics) for anticoagulant and oncology therapeutic areas. Providing medical rationale & causality assessment for Phase III & solicited case reports Proactively following up adverse events to obtain pertinent medical information (ad-hoc, targeted and expedited queries) Identifying potential signals, ESRs and Events of Special Interest, reporting SUSARs to client Medical review including adverse event selection, seriousness criteria, MedDRA coding labeling, and medical assessment comment [ISCRs] Subject Matter Expert for the experimental drugs

Vadapalani, Chennai

"First call" resident for managing 180 bed cardiac specialty ward; and once a week and I was responsible to manage the 24 bed CCU.Have co-published two papers exploring the benefits of Bare Metal Stents (cobalt chromium, by Dr YVC) and Drug Eluting Stents (DEC, by Dr KNR) along with a team of cardiologists undergoing DNB certification

Bachelor Of Medicine, Bachelor Of Surgery (Mbbs), Physician

Activities and Societies: Part of organizing and enforcing committee for inter-college MBBS cultural meeting (Plexus)One year internship.

12, Science & Maths

Completed higher secondary schooling in Anglo-Indian syllabus, with 90-95% marks in Physics, Biology and Chemistry.