Medical Reviewer- Device Safety

Job Description

TCS (Tata Consultancy Services) is seeking for  an experienced Medical Reviewer (Device Safety) to join their  pharmacovigilance function. This is a  full-time role which specifically focuses  on medical device safety, conducting clinical review of safety cases, making causality and seriousness assessments, and authoring high-quality medical narratives.

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:

You need to have a deep  understanding of pharmacovigilance frameworks, adverse event assessment device, deficiency evaluation, and IMDRF coding.

Narrative and Documentation Skills:

The clinical narratives written by you need to be clear, accurate and  standalone,regulation-compliant, internally consistent,, and writing standard something that holds up to external scrutiny, is  something that the reports should have

Interpersonal and Communication Skills:

 You need to communicate clinical reasoning clearly  both in writing and in conversation  is essential and need to have regular coordination with Clinical Safety Personnel, the Clinical Science Group, and internal teams.

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.

Benefits

Professional Environment:

 The professional environment is  something that every employee needs  the same    as  is offered here ,the  structured pharmacovigilance team  and working on complex device safety cases,  helps you in building expertise that is directly applicable across the pharmaceutical and medical device industry.

Career Advancement:

This role positions you to develop deep expertise in IMDRF frameworks, device-specific PV methodology, and clinical signal detection skills. These are the skills  that are increasingly in demand.