Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Senior Manager, Process Compliance Review and Analysis – Fortrea

Discover more

management

Management

Manager

Location

Pune, India

Job Type

Full-time

Experience Required

10+ years of experience in the Pharmaceutical, Biotechnology, or CRO industry, with solid expertise in Pharmacovigilance (PV), Safety Writing, Quality Management, Compliance, CAPA, and Process Improvement.
Experience leading quality initiatives across multiple global safety projects is required.

Estimated Salary Package (Market Standard)

₹28 – ₹40 LPA (approx.), depending on experience, domain expertise, and interview performance.

Job Overview

Discover more

South Asians & Diaspora

pharmaceutical industry

Pharma

Jobs

Business & Corporate Law

The Senior Manager, Process Compliance Review and Analysis is responsible for driving quality, compliance,



and process excellence across Pharmacovigilance (PV) and Safety Writing projects. The role focuses on implementing quality management systems, ensuring regulatory compliance, leading CAPA initiatives, supporting audits and inspections, and promoting continuous process improvement across client engagements.

Key Responsibilities

Implement and manage quality processes across PV and Safety Writing projects.
Ensure quality, compliance, and CAPA deliverables are completed on time.
Drive quality culture and continuous process improvement initiatives.
Lead CAPA management, audit readiness, and regulatory inspection support.
Monitor quality metrics, identify trends, and recommend corrective and preventive actions.
Establish and manage feedback mechanisms across projects.
Serve as the quality and regulatory process expert for internal teams and clients.
Support the standardization of quality processes and operational excelle

📌 Senior Manager, Process Compliance Review and Analysis (Pune)
🏢 The Pharma Daily - Powered by Vigisolvo
📍 Pune