Fortrea Hiring Functional Quality Specialist I in Pune – Hybrid Pharmacovigilance Role

Fortrea is hiring for the position of Functional Quality Specialist I at its Pune location under a hybrid work model. This is a full-time opportunity within the pharmacovigilance and clinical safety quality function, supporting global regulatory submissions and post-marketing safety operations. The opening is for one Functional Quality Specialist I role, suited for professionals with 2+ years of experience in pharmacovigilance, safety writing, or quality review within a CRO, pharmaceutical, or biotechnology environment. The role is based in Pune, Maharashtra, with flexibility for remote work as per project requirements.

This position is ideal for candidates looking to grow their careers in drug safety quality, global regulatory compliance, and clinical research operations while working with international sponsors and regulatory agencies.

Company Overview

Fortrea is a leading global contract research organization providing comprehensive clinical development, safety, and regulatory solutions to pharmaceutical, biotechnology, and medical device companies worldwide. Built with a strong focus on scientific rigor, regulatory compliance, and operational excellence, Fortrea supports clients across the entire product lifecycle, from early clinical development to post-marketing surveillance.

The organization is widely recognized for its expertise in pharmacovigilance, clinical safety, regulatory writing, and quality management systems. Fortrea’s teams work closely with global sponsors to ensure patient safety, data integrity, and compliance with international regulations including FDA, EMA, ICH, GCP, and GVP requirements.

Working at Fortrea offers exposure to complex global safety programs, cross-functional collaboration, and structured professional development within a regulated and quality-driven environment.

Job Role & Responsibilities

The Functional Quality Specialist I is responsible for performing quality review activities, supporting CAPA implementation, and ensuring audit readiness across pharmacovigilance and clinical safety operations. The role involves detailed review of safety cases, regulatory documents, and medical information activities for global clients.

Quality Review & Metrics Management

Perform quality review of assigned safety cases and regulatory documents
Assist in compiling quality metrics and identifying quality trends
Support periodic client quality reviews and quality performance discussions
Contribute to continuous improvement initiatives through trend analysis

CAPA & Quality Systems Support

Assist in preparation and tracking of corrective and preventive action plans
Ensure CAPA implementation with documented evidence in coordination with project managers
Support development and maintenance of Quality Management Plans for assigned projects

Pharmacovigilance & Safety Operations

Review safety reports and regulatory documents including Annual Reports, PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, SPCs, and Medication Guides
Support end-to-end adverse event processing for clinical trial and post-marketing safety data
Manage and review expedited adverse events, product quality complaints, and medical information queries
Ensure timely submission to clients and regulatory authorities as per agreed timelines

Audit Readiness & Regulatory Support

Assist in process reviews and monitor audit readiness for assigned processes
Coordinate with project teams to support client and sponsor audits and regulatory inspections
Provide quality support during regulatory inspections with guidance from Quality Leads or Managers

Training & Process Improvement

Assist in designing, tracking, and updating training schedules and training materials
Guide safety associates on call handling and safety data intake processes as required
Participate in quality forums to identify process gaps and improvement opportunities
Analyze operational data and suggest strategies for process excellence

Medical Information & Data Management

Review and respond to medical information queries and product quality complaints via phone, email, or written communication
Review recorded safety and medical information data captured through multiple channels
Execute safety data management activities including call intake review, documentation review, and case follow-up
Perform additional quality support activities including reconciliation, metrics tracking, and ongoing QC of defined process steps

Eligibility / Qualifications

This role is suitable for professionals with a strong foundation in pharmacovigilance, safety writing, and quality review within regulated environments.

Educational Qualifications

Eligible educational backgrounds include:

MBBS, BDS, BAMS, BHMS, B.Pharm, M.Pharm, PharmD, B.Sc Life Sciences, M.Sc Life Sciences, Nursing, Medical Sciences, Biological Sciences, PhD in Life Sciences or related disciplines

Fortrea may consider relevant and equivalent industry experience in lieu of formal educational qualifications.

Experience Requirements

Minimum 2+ years of experience in pharmaceutical, biotechnology, or CRO industry
Prior experience in pharmacovigilance, safety writing, peer review, or quality review is required
Strong knowledge of case processing, adverse event reporting, and regulatory documentation

Technical & Regulatory Knowledge

Good understanding of medical and drug terminology
Knowledge of GCP, GVP, ICH guidelines, and global regulatory requirements
Familiarity with FDA and EU pharmacovigilance regulations
Proficiency in Microsoft Office applications

Location & Salary

Job Location: Pune, Maharashtra, India
Work Model: Hybrid / Remote (as per project needs)

Fortrea Functional Quality Specialist Pharmacovigilance

Application Process

Interested and eligible candidates must apply through Fortrea’s official career portal using the link below:

Apply Online:
https://fortrea.wd1.myworkdayjobs.com/Fortrea/job/Pune/Functional-Quality-Specialist-I_26444

Candidates are advised to apply before 11 February 2026, as the position is nearing the application deadline.

Frequently Asked Questions (FAQs)

Who can apply for the Functional Quality Specialist I role at Fortrea?
Candidates with 2+ years of experience in pharmacovigilance, safety writing, or quality review can apply.

Is this role suitable for pharmacy and life science graduates?
Yes. Pharmacy, life sciences, medical sciences, and related healthcare backgrounds are eligible.

Is this a remote role?
The role follows a hybrid model with partial remote work depending on project needs.

Does this role involve regulatory inspections and audits?
Yes. The role supports audit readiness and regulatory inspections for global sponsors.

Is this a permanent position?
Yes. This is a full-time permanent role.