Our specialists’ previous employers

HIRE Pharmacovigilance Associates

Prathik Kawale

Senior Safety & Pharmacovigilance Specialist

Prathik Kawale is a Senior Safety & Pharmacovigilance Specialist with 9+ years of experience in ICSR case processing, quality control, CAPA, and compliance with global regulatory standards (ICH-GCP, E2B, SAE). He leads workflow coordination, training, and audit readiness activities while driving process improvements in global pharmacovigilance operations. Skilled in Argus, ARISg, and Oracle Safety, she ensures data accuracy, regulatory compliance, and seamless collaboration with cross-functional and client teams.

Argus

ARISg

Audit Readiness

CAPA/RCA

ICSR Case Processing

MedDRA Coding

MS Excel/PowerPoint

Oracle Safety

SOP Compliance

Workflow & Tracker Management

Rajiv Patil

Senior Pharmacovigilance Specialist

Rajiv Patil is a Senior Pharmacovigilance Specialist with 8+ years of experience in literature surveillance, ICSR processing, medical coding, and drug safety operations. He specializes in literature screening, case triage, and safety reportability assessments using MedDRA/WHODD and global regulatory frameworks (FDA, EMA, MHRA, TGA). Skilled in workflow management, CAPA support, and mentoring teams, Rajiv ensures compliant and efficient pharmacovigilance delivery for global clients

CAPA Tracking

Database QC & Reconciliation

Dialog

DST

Embase

ICSR Processing

Literature Surveillance

Literature-Based ICSR Identification

MedDRA

MedDRA/WHO-DD/CPD Coding

Narrative Writing

PSUR/PBRER/RMP Support

+4 More

Suman Choudhary

Senior Pharmacovigilance Associate

Suman Choudhary is a Senior Pharmacovigilance Associate with 9 years of experience in drug safety operations, ICSR case processing, literature surveillance, and aggregate reporting (PBRER, PSUR, DSUR). Skilled in MedDRA coding, quality review, workflow management, and regulatory submissions (US FDA, EMA, MHRA, Health Canada), she supports end-to-end pharmacovigilance delivery while mentoring teams and ensuring audit-ready compliance.

Argus

ARISg

Case Entry

Case Triage

CIOMS/MedWatch

ICSR Processing

Literature Surveillance

MedDRA Coding

MS Office

Narrative Writing

Patient Counseling

Prescription Handling

+4 More

Sweta Taral

Senior Safety & Pharmacovigilance Specialist

Sweta Taral is a Senior Safety & Pharmacovigilance Specialist with 9 years of experience across end-to-end ICSR case processing, quality review, compliance, and team leadership in clinical and post-marketing environments. Skilled in MedDRA/WHODD coding, CAPA, workflow management, and regulatory frameworks (GVP, ICH-GCP), she drives operational excellence, ensures audit-ready documentation, and mentors teams while collaborating with cross-functional stakeholders.

Argus

ARISg

Audit Readiness

CAPA/RCA

Client/Investigator Coordination

ICSR Processing & QC

InForm

MedDRA

Medidata

MS Office

Reconciliation

WHO-DD

Vaibhav Nale

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.

Argus

ARISg

Audit Readiness

CAPA/RCA

Client/Investigator Coordination

Compliance Tracking

ICSR Processing

ICSR Processing & QC

InForm

MedDRA

Medical Reviewer Coordination

Medidata

+3 More

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COO, Growth-Stage Biotech

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Medical Writer

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Data QC Specialist

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Arjun Mehta

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Rajesh Chaturvedi

Senior Clinical Data Manager

Bioinformatics

Clinical Operations

Pharmacovigilance

+5 Other

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Contract initiated...

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Expertise

Clinical Data Manager

Medical Writer

Regulatory Specialist

Biostatistician

Data Engineer / Data Scientist

+9 more

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