Company: TCS
Role: Pharmacovigilance – Submission Specialist
Work Location: Mumbai
Experience: 1–4 years of relevant experience in Pharmacovigilance
Job Function: Business Process Services
Role Level: Executive
Job ID: 379660
About the Role
TCS is hiring experienced Pharmacovigilance Submission Specialists to join our Drug Safety team. The ideal candidate will have hands-on experience in case processing and global submissions to health authorities using ARGUS and will contribute to ensuring regulatory compliance and high-quality deliverables.
Key Responsibilities
Perform case processing activities in the ARGUS safety database, ensuring accuracy and compliance with global pharmacovigilance regulations.
Manage and execute global safety submissions to Health Authorities within required timelines.
Ensure the quality, accuracy, and consistency of individual case safety reports (ICSRs).
Collaborate with internal teams to ensure timely resolution of queries and completion of case processing workflows.
Maintain compliance with company standard operating procedures (SOPs) and global regulatory requirements.
Support audits and inspections related to pharmacovigilance operations and submissions.
Desired Candidate Profile
Qualifications:
Mandatory: B.Pharm / M.Pharm
Eligible: BAMS / BHMS / BDS / M.Sc (Biotechnology, Zoology)
Skills & Experience:
1–4 years of relevant experience in Pharmacovigilance, specifically in case processing and global submissions.
Proficiency in ARGUS Safety Database.
Strong understanding of pharmacovigilance principles, regulatory requirements, and submission workflows.
Excellent attention to detail, communication, and documentation skills.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Queensland |Melbourne :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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