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Roche Hiring Patient Safety Partner in PV

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Roche

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences, Medical degree

Mumbai

3 years

Verified Job

Online Application

Roche is actively hiring a Patient Safety Partner in Mumbai, offering a strong opportunity for professionals in pharmacovigilance (PV), drug safety, and risk management. This role is ideal for candidates with 3+ years of PV experience looking to work in a globally regulated environment aligned with FDA, EMA, and ICH guidelines.

If you are aiming to build a career in pharmacovigilance jobs in India, especially within a top multinational pharmaceutical company, this opening provides exposure to global safety systems, risk management strategies, and regulatory compliance.

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๐Ÿ“Œ Job Overview

  • Role: Patient Safety Partner
  • Location: Mumbai, India
  • Experience: Minimum 3 years in Pharmacovigilance
  • Qualification: Life Sciences / Pharmacy / Medical degree
  • Company: Roche
  • Job Type: Full-time
  • Application Deadline: May 8, 2026

๐Ÿ” Key Responsibilities (Pharmacovigilance & Drug Safety)

The Patient Safety Partner at Roche will act as a custodian of pharmacovigilance excellence, ensuring compliance with global and Indian PV regulations.

Core PV Activities:

  • Manage Individual Case Safety Reports (ICSRs) including data collection and review
  • Conduct signal detection and signal management for local products
  • Prepare and submit aggregate safety reports to health authorities
  • Handle Risk Management Plans (RMPs) and safety communications (DHPCs)
  • Maintain Pharmacovigilance System Master File (PSMF)
  • Ensure safety labeling and regulatory compliance

Quality & Compliance:

  • Perform root cause analysis (RCA) and manage CAPA processes
  • Ensure data integrity across PV systems like Veeva Vault
  • Maintain audit and inspection readiness
  • Oversee PV training compliance for teams and vendors

Strategic & Cross-functional Work:

  • Collaborate with medical affairs, regulatory, and global safety teams
  • Support product launch readiness with safety insights
  • Contribute to local and global safety strategies

๐ŸŽ“ Qualifications & Skills Required

Educational Requirements:

  • Degree in Pharmacy, Life Sciences, or Medicine

Experience:

  • Minimum 3 years of pharmacovigilance experience
  • Exposure to clinical trial and post-marketing safety

Technical Skills:

  • Knowledge of global PV regulations (FDA, EMA, ICH)
  • Experience with Veeva Vault Safety, ArisG systems
  • Strong understanding of drug safety monitoring and compliance

Soft Skills:

  • Strategic thinking and stakeholder management
  • Strong communication and analytical abilities
  • Problem-solving and process optimization mindset

๐Ÿ’ผ Why Join Roche?

Working at Roche offers a high-impact career in drug safety and pharmacovigilance:

  • Opportunity to work in a globally recognized pharma company
  • Exposure to advanced PV systems and global safety standards
  • Collaborative environment with cross-functional teams
  • Career growth in regulatory affairs and pharmacovigilance leadership

๐Ÿš€ How to Apply

Application Link

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