Healthcare, Life Sciences, Drug Safety And Pharmacovigilance Services

HEALTHCARE, LIFE SCIENCES, DRUG SAFETY AND

PHARMACOVIGILANCE

Premarketing and Post-marketing Global Clinical trials/studies Consulting services:

Operations and Strategy (Workflow monitoring, resource planning and management)

Project Management (Initiation, organizing and executing Operations)

Pharmacovigilance contracts (Work order/contract,

Proposal/agreement)

Safety management plan (SMP)

Safety Data exchange agreement (SDEA)

Standard Operating procedure (SOP) development and management

ICSRs monitoring & Processing

Safety Databases (Argus, ArisG)

Medical Coding (MedDRA, WHODD)

Literature Surveillance

Medical Narrative Writing

Regulatory Reporting and submissions

Aggregate reports

- Signal Detection, benefit risk and management

- Periodic and developmental safety update report (PSUR & DSUR)

- Risk management Plan (RMP)

Safety sections of Investigator’s Brochure (IB), SmPC/label Safety data analysis and metrics

Pharmacovigilance System Master file (PSMF)

Vendor management (shortlist and manage CRO’s by

implementing SLA’s and KPI)

Performance management

Training of PV concepts

Team and Client Management

A detailed proposal will be sent based on the activities expected to be performed. Thanks and regards

Dr Sripadaraja Joish BDS, MBA

Healthcare, Life Sciences, Drug Safety and Pharmacovigilance Consultant, Bangalore - India Contact: *************@*****.***; Mobile: +91-914*******

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