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Novotech Hiring | Statistical Programmer, Document Management (TMF), Pharmacovigilance, Clinical Document Specialist

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Novotech is actively hiring across India for multiple roles in clinical research, pharmacovigilance, and statistical programming. This is a strong opportunity for candidates in B.Pharm, M.Pharm, Life Sciences, Biostatistics, and Clinical Research domains to enter or grow within a global CRO environment.

These openings span across Statistical Programming, Pharmacovigilance (PV), and TMF (Trial Master File) operations, making it ideal for candidates targeting desk-based clinical research careers.


๐Ÿ” Open Positions (5 Roles)

1. Statistical Programmer II

  • Work on clinical trial datasets and statistical outputs
  • Collaborate with biostatisticians
  • Develop SAS programming solutions
  • Mentor junior programmers

2. Document Management Associate (DMA)

  • Manage Trial Master File (TMF) (eTMF + paper)
  • Ensure compliance with ICH-GCP & SOPs
  • Coordinate with study teams

3. Pharmacovigilance Associate

  • Handle ICSR processing (SAE/SUSAR/AE)
  • Safety database setup & monitoring
  • Follow ICH-GCP, regulatory compliance
  • Manage safety mailbox & reporting

4. Clinical Document Specialist (CDS)

  • Maintain and manage TMF documentation
  • Ensure quality and completeness
  • Support clinical trial documentation workflows

5. Senior Document Management Associate (SDMA)

  • Lead TMF management activities
  • Perform QC reviews
  • Handle multiple projects and compliance

๐Ÿง  Key Responsibilities (Across Roles)

  • Clinical trial documentation & TMF management
  • Pharmacovigilance case processing & safety reporting
  • Statistical programming using SAS
  • Regulatory compliance (ICH-GCP, SOPs)
  • Data quality checks & documentation QC
  • Cross-functional collaboration with clinical teams

๐ŸŽ“ Qualifications Required

  • B.Pharm / M.Pharm / BSc / MSc / Biostatistics / Life Sciences
  • Experience:
    • Fresher to experienced (role dependent)
    • TMF / PV / SAS / Clinical documentation preferred
  • Strong understanding of:
    • ICH-GCP guidelines
    • Clinical trial lifecycle
    • Pharmacovigilance basics (ICSR, MedDRA, safety reporting)

๐Ÿ’ผ Benefits of Working at Novotech

  • Global CRO exposure
  • Strong career growth in clinical research & PV
  • Opportunity to move into:
    • Clinical Data Management
    • Regulatory Affairs
    • Biostatistics
  • Structured SOP-driven environment
  • Work on international clinical trials

๐Ÿ“Œ Why This Job is High Value

This hiring aligns with trending search queries like:

  • โ€œPharmacovigilance jobs India 2026โ€
  • โ€œClinical research TMF jobs Indiaโ€
  • โ€œStatistical programmer pharma jobs Indiaโ€
  • โ€œCRO jobs for B.Pharm freshersโ€

These roles are especially valuable for candidates seeking:

  • Non-field (desk) jobs
  • Entry into global CRO companies
  • Career transition into data-driven healthcare roles

๐Ÿ“ฉ How to Apply

Application Link For Statistical Programmer II

Application Link For Document Management Associate (DMA)

Application Link For Pharmacovigilance Associate

Application Link For Clinical Document Specialist (CDS)

Application Link For Senior Document Management Associate (SDMA)

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