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Vaibhav Nale
Lead Pharmacovigilance Professional (PV Associate III)
Lead Pharmacovigilance
Vaibhav Nale is a Lead Pharmacovigilance Professional with 10+ years of experience in aggregate safety reporting, signal management, and drug safety operations. He specializes in authoring PADERs, PSURs, DSURs, and RMPs, managing regulatory submissions, and leading global safety teams. Skilled in MedDRA/WHO-DD coding, literature surveillance, SOP development, and audit/inspection readiness, Vaibhav ensures compliant and efficient PV delivery across clinical and post-marketing settings.
FORMERLY AT
Teva Pharmaceuticals
LOCATION
Chennai, India
AVAILABILITY
Full-time
Skills
Argus
ARISg
Audit Readiness
CAPA/RCA
Client/Investigator Coordination
Compliance Tracking
ICSR Processing
ICSR Processing & QC
InForm
MedDRA
Medical Reviewer Coordination
Medidata
MS Office
Reconciliation
WHO-DD
Work Experience
Senior Drug Safety Specialist
Parexel International
April 2021 – July 2021
- Led PV projects ensuring regulatory compliance on reporting timelines.
- Monitored metrics, implemented CAPA plans, and performed QC on safety data.
- Acted as client interface for PV projects, regulatory updates, training, and safety process set-up.
TECHNOLOGIES
ICSR Processing, CIOMS/MedWatch, SUSAR Unblinding, Audit Readiness
Drug Safety Specialist
Parexel International
November 2018 – March 2021
-
Performed case intake, triage, coding, causality assessment, narrative authoring, and E2B submissions. Oversaw mailbox tracking and reconciliation activities.
TECHNOLOGIES
MedDRA / WHO-DD / CDD Coding, E2B Submission, Case Triage
