Medical Reviewer - Device Safety

Job Description

TCS (Tata Consultancy Services) is seeking an experienced Medical Reviewer (Device Safety) to join our pharmacovigilance function. Part of the Tata Group, TCS operates across 46 countries with over 500,000 consultants and is listed on both BSE and NSE. This is a permanent, full-time role focused specifically on medical device safety  conducting clinical review of safety cases, making causality and seriousness assessments, and authoring high-quality medical narratives. If you hold an MBBS or MD and have a background in adverse event reporting or device safety, this role is built for you. Candidates newer to this space but with a strong clinical foundation will also be considered, though prior exposure to adverse event reporting is expected.

Key Responsibilities

Safety Case Medical Review:

The majority of your time goes into the medical review of safety cases in the clinical database. For Device Deficiency reports, you make a clinical seriousness assessment determining whether the deficiency has the potential to cause or contribute to an Adverse Event. That judgement is yours to make and yours to defend.

Causality Assessment:

Every Adverse Event that comes through requires a causality assessment. In many cases you will need to write out your rationale in sufficient detail that it can be reviewed and externally justified. If a case has been coded Non-Serious and your review tells you otherwise, you upgrade it  that decision is yours.

Comprehensive Report Review:

Beyond individual cases, you are responsible for the full medical review of clinical cases, solicited and spontaneous reports, and literature articles. For each, you work through seriousness, labelling, causality, company causality statements, and IMDRF Annex E and F coding. Every report that leaves your desk should be complete, cohesive, and in line with regulatory requirements and internal SOPs  whether it covers a single product or a product group, at national or global scope.

Signal and Public Health Escalation:

A critical part of this role that often goes underemphasised  if something in a safety report looks like it could be a serious signal or an urgent safety issue, you catch it and escalate it immediately. You serve as a clinical filter for issues that genuinely need to go up the chain quickly.

Narrative Authoring:

The final narrative in a safety report needs to read as a clear, standalone, chronologically ordered clinical story. You review it, edit it, and own the final version. It should read like a clinician understood the case and wrote it up properly  not like a form was completed.

Query Management and Cross-functional Coordination:

You will generate medically relevant queries, send them out, and track them through to closure. You will maintain regular contact with Clinical Safety Personnel throughout the review process and occasionally with the Clinical Science Group to ensure all necessary queries are resolved before a report is finalised.

Device-Specific Analytical Review:

For device safety cases, you will verify that the correct analytical strategy is applied when reviewing clusters of similar incidents  including confirming that the right IMDRF codes are being used as the search basis for grouping related events. This requires both clinical and technical familiarity with how device incidents are classified.

Product Knowledge Development:

Over time, you are expected to develop a thorough working knowledge of the disease biology areas relevant to your assigned products  both marketed devices and those in development. Staying current on critical Adverse Events and emerging safety concerns is part of how this role is meant to function, not something you do only when a case demands it.

Skills Required

Clinical Review Competency:

Ability to make sound, defensible clinical judgements on device deficiency seriousness and AE causality. Prior experience in a similar medical reviewer role within a pharmacy or medical device company is a clear advantage.

Pharmacovigilance and Regulatory Knowledge:

Solid understanding of pharmacovigilance frameworks, adverse event assessment and management, device deficiency evaluation, and IMDRF coding.

Narrative and Documentation Skills:

Ability to produce clear, accurate, standalone clinical narratives. Reports must be regulation-compliant, internally consistent, and written to a standard that holds up to external scrutiny.

Interpersonal and Communication Skills:

Regular coordination with Clinical Safety Personnel, the Clinical Science Group, and internal teams. The ability to communicate clinical reasoning clearly  both in writing and in conversation  is essential.

Deadline Management:
Regulatory work is deadline - driven role

Qualification Required

Education:

MBBS or MD from a recognised institution.

Experience:

Experience with adverse event assessment and management, device deficiency evaluation, IMDRF coding, and clinical narrative writing. Prior experience in a medical reviewer role within a pharma or medical device company will be a strong advantage.

Registration:

Valid medical registration with the Medical Council of India (MCI) or equivalent body is required.

Eligibility:

This position is open to Indian nationals only.

Benefits

Professional Environment:

You will work within a structured pharmacovigilance team on complex device safety cases, building expertise that is directly applicable across the pharmaceutical and medical device industry.

Career Advancement:

Device safety is a growing specialisation within pharmacovigilance. This role positions you to develop deep expertise in IMDRF frameworks, device-specific PV methodology, and clinical signal detection  skills that are increasingly in demand.

Compensation:

Competitive salary package based on clinical experience, expertise, and seniority.