TCS Hiring for Pharmacovigilance Submission Specialist in Mumbai with 1–4 years experience in Argus case processing and global safety submissions.
Tata Consultancy Services (TCS), a global leader in IT and business process services, is actively recruiting Pharmacovigilance Submission Specialists for its Mumbai operations. This opportunity is ideal for life sciences professionals with 1–4 years of experience in Pharmacovigilance, particularly those who have handled case processing in Argus and have exposure to global safety submissions to health authorities. TCS Hiring for Pharmacovigilance Submission Specialist
TCS partners with leading pharmaceutical companies worldwide to support patient safety, regulatory compliance, and post-marketing surveillance. In this role, candidates will work within structured PV workflows, follow global regulatory standards, and contribute to safety submissions that impact patient well-being across multiple geographic regions. TCS Hiring for Pharmacovigilance Submission Specialist
Key Highlights
| Feature | Details |
|---|---|
| Job Title | Pharmacovigilance Submission Specialist |
| Company | Tata Consultancy Services (TCS) |
| Location | Mumbai |
| Experience Required | 1–4 years in Pharmacovigilance |
| Qualification | B.Pharm, M.Pharm, BHMS, BAMS, BDS, M.Sc (Biotech/Zoology) |
| Job Function | Business Process Services |
| Role Category | Health Informatics / Clinical Informatics |
| Department | Healthcare & Life Sciences |
| Employment Type | Full-time, Permanent |
| Skills Needed | Argus case processing, global submission procedures, medical coding, PV compliance |
| Industry Type | IT Services & Consulting |
| Applicants | 100+ (as per posting) |
About Tata Consultancy Services (TCS)
TCS is one of the world’s largest IT consulting and business services organizations, serving pharmaceutical, healthcare, and life sciences clients globally. Within Pharmacovigilance, TCS supports key safety functions such as case processing, regulatory submissions, literature screening, quality checks, aggregate reporting support, and compliance tracking. TCS Hiring for Pharmacovigilance Submission Specialist
The Pharmacovigilance Submission Specialist role is critical within the global safety network. Employees in this position gain exposure to regulatory guidelines across geographies, modern safety databases like Argus, and global health authority submission processes. TCS offers structured training, performance-driven work culture, cross-functional learning, and strong career progression prospects within PV and related disciplines. TCS Hiring for Pharmacovigilance Submission Specialist
Role Overview: Pharmacovigilance Submission Specialist
The Pharmacovigilance Submission Specialist plays a vital role in processing adverse event (AE) cases, ensuring documentation accuracy, and coordinating global submissions. Successful candidates will be fully competent in case processing steps within Argus and will understand the timelines, formats, and regulatory requirements for different regions. TCS Hiring for Pharmacovigilance Submission Specialist
This role requires an analytical mindset, attention to detail, familiarity with safety databases, and knowledge of global PV submission expectations such as E2B formats, regional rules, and compliance timelines. TCS Hiring for Pharmacovigilance Submission Specialist
Detailed Job Responsibilities
1. Case Processing in Argus
- Perform end-to-end processing of Individual Case Safety Reports (ICSRs).
- Enter AE information into Argus with high accuracy and completeness.
- Evaluate seriousness, expectedness, medical coding (MedDRA), narrative writing, and data verification.
- Ensure cases are processed in line with SOPs and global regulatory guidelines.
2. Global Health Authority Submissions
- Prepare safety cases for global submission in accordance with regional regulatory requirements.
- Validate case data before transmission to health authorities (E2B, XML formats, etc.).
- Ensure compliance with submission timelines for EMA, MHRA, FDA, PMDA, and other agencies.
- Track submissions, generate compliance reports, and participate in quality improvement discussions.
3. Documentation & Compliance
- Maintain complete, audit-ready documentation for all case activities.
- Follow local and global PV processes, procedural documents, and quality expectations.
- Support data quality initiatives and implement corrective actions where needed.
4. Safety Follow-Up Activities
- Identify missing information and initiate follow-up communications as per SOPs.
- Record responses accurately in Argus or relevant databases.
- Maintain consistency in follow-up documentation and compliance milestones.
5. Quality, Systems, and Process Improvement
- Participate in internal quality checks, audits, and CAPA implementation.
- Provide input for process enhancements, workflow optimization, and system upgrades.
- Support testing and implementation of new PV tools or changes to existing systems.
6. Collaboration with Cross-Functional Teams
- Work with medical reviewers, quality teams, submission teams, and project leads.
- Communicate case status, escalate delays, or highlight critical issues.
- Contribute to a performance-driven and teamwork-oriented culture.
Educational Qualifications
Eligible candidates must hold a degree in one of the following: TCS Hiring for Pharmacovigilance Submission Specialist
Undergraduate Degrees:
- B.Pharm
- BHMS
- BAMS
- BDS
- B.Sc (Science, Biotechnology, Chemistry, Zoology, etc.)
- Any Graduate with life sciences background preferred
Postgraduate Degrees:
- M.Pharm
- M.Sc (Biotechnology, Zoology, Chemistry, Life Sciences)
These qualifications help ensure familiarity with medical terminology, drug safety concepts, basic regulatory frameworks, and scientific interpretation.
Required Experience and Core Skills
Experience
- 1–4 years of experience in Pharmacovigilance, preferably with case processing and submission experience.
- Prior experience supporting global pharma clients or CROs is an advantage.
Technical Skills
- Strong command of Argus Safety for case processing.
- Understanding of E2B submissions, XML conversion, validation rules.
- Knowledge of MedDRA coding and WHO Drug Dictionary.
- Understanding of global regulatory guidelines (ICH, FDA, EMA, MHRA, etc.).
Functional Skills
- Ability to interpret medical information and convert it into structured safety data.
- High attention to detail.
- Strong documentation skills.
- Good written and verbal communication.
- Capability to work under fixed timelines.
Behavioral Competencies
- Accountability and adherence to compliance.
- Teamwork and a positive attitude toward feedback.
- Willingness to adapt to changing regulatory requirements and client needs.
Why This Role Is Important
Pharmacovigilance Submission Specialists ensure patient safety by making sure adverse events are reported correctly and on time to regulatory authorities around the world. The accuracy of submissions has direct consequences on public health, compliance, and a company’s global reputation. TCS Hiring for Pharmacovigilance Submission Specialist
This role is at the crossroads of data quality, regulatory compliance, and real-world patient outcomes, making it ideal for professionals who want a meaningful career in drug safety. TCS Hiring for Pharmacovigilance Submission Specialist
Career Progression at TCS
Depending on performance, skills, and experience, candidates can progress to:
- Senior PV Associate
- Safety Submission Lead
- PV Quality Reviewer
- Aggregate Reports Associate
- PV Team Leader
- PV Manager / Specialist Roles
- Shift toward Regulatory Affairs, Clinical Safety, or Signal Detection
TCS offers learning paths through internal training platforms and client-specific certification programs. TCS Hiring for Pharmacovigilance Submission Specialist
Work Environment and Culture
TCS provides a stable, process-driven workplace with emphasis on: TCS Hiring for Pharmacovigilance Submission Specialist
- Global PV standards
- Quality and compliance
- Structured workflows
- Regular training and team collaboration
- Employee wellbeing and professional development
Employees work closely with global pharma clients, regulatory expectations, and advanced PV systems. TCS Hiring for Pharmacovigilance Submission Specialist
How to Apply
To apply for the Pharmacovigilance Submission Specialist – Mumbai position: TCS Hiring for Pharmacovigilance Submission Specialist
- Visit the job portal where the opening is posted.
- Register or log in to your account.
- Complete the online application with accurate information.
- Upload your updated resume clearly highlighting:
- Argus case processing experience
- Global submission exposure
- Regulatory knowledge
- Technical tools used
- Keep academic documents and experience certificates ready for verification during the interview process.
Resume Tip:
Showcase exact responsibilities you handled—case volume per day, submission types, quality scores, follow-up management, and system proficiency.
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