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Navitas hiring for PVQA, Aggregate & Signal, CDM, SAS, Regulatory Affairs

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The pharma and clinical research industry in India is actively hiring across pharmacovigilance (PV), regulatory affairs, and clinical data science domains. A leading global life sciences organization, Navitas Life Sciences, is recruiting for multiple full-time roles in Bangalore and Chennai.

If you have experience in drug safety, regulatory submissions, SAS programming, or clinical data analysis, these roles offer strong career growth, global exposure, and hands-on work in regulatory-compliant environments.


๐Ÿ” Open Positions

  • QA Auditor โ€“ Pharmacovigilance (PV)
  • Safety Specialist II (Aggregate Reports & Signal Management)
  • Clinical Data Analyst
  • Senior SAS Programmer
  • Regulatory Associate / Junior Regulatory Associate ( 0 -3 Years)

๐Ÿง  Key Responsibilities

Pharmacovigilance & Safety Roles

  • Conduct GVP/GCP audits and ensure compliance with global PV systems
  • Author and review aggregate safety reports (PSUR, PBRER, DSUR)
  • Perform signal detection, validation, and risk management planning
  • Handle CAPA management and audit readiness activities
  • Analyze safety data and generate line listings & summary tabulations

Regulatory Affairs Roles

  • Prepare and publish submissions (IND, NDA, ANDA, DMF) in CTD/eCTD format
  • Ensure compliance with USFDA, EMA, and global regulatory guidelines
  • Manage document formatting, hyperlinking, and submission validation
  • Collaborate cross-functionally for submission planning and execution

Clinical Data & SAS Roles

  • Create TFLs (tables, listings, figures) and derived datasets
  • Develop and validate SAS macros (SDTM, ADaM datasets)
  • Support statistical analysis and clinical data reporting
  • Work on multiple studies while ensuring timeline adherence

๐ŸŽ“ Qualifications & Eligibility

  • Education: B.Pharm, M.Pharm, MSc, Life Sciences, Engineering, or related fields
  • Experience Requirements:
    • QA Auditor (PV): 5+ years PV system + 3+ years auditing
    • Safety Specialist II: 3โ€“6 years PV & aggregate reporting
    • Clinical Data Analyst: 2.5โ€“3 years + SAS skills
    • Senior SAS Programmer: 5โ€“8+ years with SDTM/ADaM expertise
    • Regulatory Roles: (0 – 3 years)
  • Strong knowledge of ICH, GCP, GVP, USFDA guidelines
  • Proficiency in MS Office and safety databases (e.g., Argus preferred)

๐Ÿ’ผ Salary & Benefits (Estimated)

  • ๐Ÿ’ฐ Salary Range: โ‚น3 LPA โ€“ โ‚น20 LPA (role & experience dependent)
  • ๐ŸŒ Global project exposure
  • ๐Ÿ“ˆ Career growth in regulatory and safety domains
  • ๐Ÿค Collaborative and structured work environment
  • ๐Ÿ“š Continuous learning & compliance training

๐Ÿ“ Job Locations

  • Bangalore, Karnataka
  • Chennai, Tamil Nadu

๐Ÿš€ How to Apply

Share Your resume on

recruitment.bangalore@navitaslifesciences.com

recruitment.chennai@navitaslifesciences.com

recruitment.india@navitaslifesciences.com

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