Pharmacovigilance Submission Specialist (TCS) | Mumbai | 1–4 Years Experience
Category: Pharmacovigilance / Drug Safety
Job Type: Full-Time | On-site
Job ID: 379660
Tata Consultancy Services (TCS) is hiring an experienced Pharmacovigilance Submission Specialist to support global drug safety operations. This role requires hands-on expertise in case processing, regulatory submissions, and safety database management.
Position Overview
The Pharmacovigilance Submission Specialist will be responsible for processing adverse event cases, performing regulatory submissions to global health authorities, and ensuring timely, compliant safety reporting. The role demands accuracy, strong analytical skills, and experience with ARGUS or similar PV databases.
Key Responsibilities
Perform end-to-end case processing activities, including data entry, coding, narrative preparation, and medical review support.
Manage global safety submissions to health authorities in accordance with regulatory timelines and guidelines.
Ensure compliance with Pharmacovigilance SOPs, global regulations, and quality standards.
Review and validate case data within ARGUS or relevant safety systems.
Support the Drug Safety team with accurate and timely submission deliverables.
Maintain documentation and submission records as per industry and organizational standards.
Required Experience
1 to 4 years of relevant experience in Pharmacovigilance and drug safety submissions.
Experience in case processing using ARGUS Safety Database is essential.
Exposure to global regulatory submission workflows preferred.
Educational Qualifications
B.Pharm / M.Pharm
BAMS / BHMS
BDS
MSc in Biotechnology or Zoology
Skills & Competencies
Strong understanding of Pharmacovigilance guidelines and regulatory reporting requirements.
Proficiency in safety databases, especially ARGUS.
Good analytical, documentation, and communication skills.
Ability to manage timelines and work in a quality-driven environment.
Location
Mumbai, Maharashtra, India
Job Function
Business Process Services
Role: Executive
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