Parexel, a globally recognized clinical research organization, is actively hiring for Patient Safety Specialist (Pharmacovigilance) and Senior Regulatory Affairs Associate roles in India. These opportunities are ideal for candidates looking to build or advance their careers in drug safety, ICSR processing, and regulatory affairs.
With increasing demand for pharmacovigilance jobs in India and regulatory affairs careers, these roles offer exposure to global compliance frameworks including ICH, FDA, and EMA regulations.
1. Patient Safety Specialist โ Pharmacovigilance (Hyderabad)
Key Responsibilities
- Perform ICSR processing and case assessment
- Prepare narratives, safety reports, and listings
- Ensure compliance with global safety reporting timelines
- Conduct literature review for adverse drug reactions (ADR)
- Support aggregate reporting and submissions
- Assist in audit readiness and inspection preparation
- Monitor compliance metrics and PV quality activities
- Collaborate with cross-functional teams and clients
- Support regulatory intelligence and safety submissions
Qualifications
B.Pharm, M.Pharm, Pharm.D, Life Sciences, or related field 3โ6 years of experience in Pharmacovigilance / Drug Safety Hands-on experience in ICSR processing & case management Working knowledge of safety databases (Argus, ARISg, etc.) Strong understanding of ICH guidelines and global PV regulations Good analytical, documentation, and communication skills
Salary Range
โน5 โ โน9 LPA (aligned with 3โ6 years PV experience in CROs)
2. Senior Regulatory Affairs Associate (Remote โ Bengaluru)
Key Responsibilities
- Manage US & Canada Annual Reports (CMC changes)
- Perform Module 1 authoring and eCTD submissions
- Coordinate with Regulatory Operations & Affiliates
- Maintain RIM systems and regulatory documentation
- Ensure compliance with global regulatory submission standards
- Handle multiple regulatory projects and deadlines
Qualifications
- 5+ years in Regulatory Affairs (Pharma)
- Strong understanding of US FDA & Health Canada requirements
- Experience in CMC documentation and submission planning
- Expertise in eCTD and regulatory systems
Salary Range
โน10 โ โน18 LPA (based on experience)
Why Join Parexel? (Benefits)
- Work with a global CRO leader
- Exposure to international regulatory frameworks
- Strong career growth in pharmacovigilance & regulatory affairs
- Collaborative and compliance-driven work environment
- Opportunity to work on global clinical development projects
How to Apply
Application Link For Patient Safety Specialist โ Pharmacovigilance (Hyderabad)
Application Link For Senior Regulatory Affairs Associate (Remote โ Bengaluru)
