Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Specialist - Qppv

2+ years
Not Disclosed
10 Nov. 6, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Specialist – QPPV

Location: Telangana (Sandoz)
Job Type: Full-time
Job Requisition ID: REQ-10024484
Posted: 8 Days Ago
Application Deadline: November 10, 2025 (3 days left to apply)


About the Company

Sandoz is a global leader and pioneer in sustainable Biosimilar and Generic medicines, dedicated to improving patient access worldwide. As we continue our transformative journey, we offer unique opportunities for personal and professional growth. Together, we are shaping the future of healthcare — join us and help make affordable, high-quality medicines available to more patients across the globe.


Position Overview

The QPPV Office Specialist supports the Qualified Person for Pharmacovigilance (QPPV) in developing, implementing, and monitoring quality and compliance activities across Sandoz’s global Patient Safety (PS) organization.
This role ensures adherence to internal standards and international pharmacovigilance regulatory requirements.


Key Responsibilities

  • Support the development, implementation, and management of deviations, CAPAs (Corrective and Preventive Actions), and effectiveness checks across the Patient Safety organization and other functions.

  • Assist in inspection and audit operations, including CAPA coordination, tracking, and management in the GxQEM system.

  • Contribute to PV performance oversight by creating and monitoring metrics, KPIs, and KQIs for Patient Safety and key vendors.

  • Support the QPPV in meeting legislative and regulatory requirements.

  • Participate in deviation management discussions and ensure compliance with global regulatory expectations.

  • Review emerging worldwide regulations, perform impact assessments, and recommend process updates for continued compliance.

  • Support business functions in managing deviations and quality events throughout the deviation lifecycle.

  • Contribute to QPPV Office projects and Quality Management System (QMS) initiatives.

  • Identify and escalate potential risks or compliance issues through metrics analysis and performance reports.

  • Support the development, implementation, and dissemination of Patient Safety procedures and SOPs.

  • Coordinate documentation, filing, and archival activities within the QPPV Office.


What You’ll Bring to the Role

Essential Qualifications & Experience:

  • Minimum 2 years of experience in drug development, including clinical safety, pharmacovigilance, or related areas.

  • Strong communication (written and verbal), negotiation, and problem-solving skills.

  • Proactive and results-driven with a transparent and accountable work style, even under pressure.

  • Excellent planning, coordination, and organizational abilities.

  • Proficient in computer systems and data management tools.


Desired Skills

  • Knowledge of pharmacovigilance databases and systems

  • Experience in document filing and archival

  • Familiarity with safety science and reporting practices

  • Understanding of employee training and compliance documentation


Why Sandoz?

  • Sandoz provided over 900 million patient treatments across 100+ countries in 2024.

  • With new investments in development capabilities, production sites, acquisitions, and partnerships, we are driving innovation in generics and biosimilars.

  • Experience an open, collaborative culture with a focus on learning, growth, and impact.

  • Enjoy a flexible-hybrid work environment that values diversity, teamwork, and personal development.

Join us and be part of the team shaping the sustainable future of healthcare.