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

Bose Informatics HR
5 days ago
2 min read

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.

Open Positions

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

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

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: 3–6 years PV & aggregate reporting
- Clinical Data Analyst: 2.5–3 years + SAS skills
- Senior SAS Programmer: 5–8+ 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)