Medical Reviewer 1 (MBBS / MD)

Overview

Vizen Life Sciences is looking for a qualified Medical Reviewer who is willing to bring their  clinical expertise into its pharmacovigilance function. The role is about applying the medical judgement to the review and assessment of safety cases, author clinical narratives, and serve as a first-line clinical filter for potential signals in order to ensure that  every report that leaves the team is medically accurate  and compliant to the regulations.

Key Responsibilities

• Medical case review: Conducting  clinical review of individual safety cases at the same time conducting reviews of the spontaneous reports, solicited reports, and literature articles;you will be expected to assess these reports on the basis of their seriousness, expectedness, labelling, and causality for each.

• Causality assessment: Make and document all the  independent causality assessments for adverse events and  provide clear written rationale sufficient for the  external regulatory review and justification.

• Narrative authoring: You will also be an author and so you have to review and own the final clinical narrative that you write  for each safety report ensuring that it reads as a clear, chronologically ordered, standalone clinical account in line with all the regulatory requirements.

• Signal detection & escalation: As a medical reviewer you will be the first person to identify potential safety signals or urgent public health concerns within incoming reports and will escalate those concerns immediately through the appropriate clinical channels in order to find a solution for them.

• Query management: You will review and write a lot of reports and so generating  medically relevant queries is very much necessary at the same time you will also coordinate their resolution with Clinical Safety Personnel and the Clinical Science Group, and ensure all outstanding queries are closed properly according to compliance before the report is finalised.

• Product knowledge: A Medical reviewer is the first one to identify the health concerns and so it is crucial that you  develop and maintain thorough knowledge of disease biology and safety profiles for assigned products, staying current on critical adverse events and emerging safety concerns.

Required Skills

• To make better decisions you need to have strong clinical judgement .

• As you will be working in a pharmacovigilance team you need to have in-depth knowledge and experience of the pharmacovigilance frameworks and regulatory guidelines.

• You will be an author who will write and document many events and so your clinical narrative writing should be clear, accurate, standalone, and regulation-compliant

• You will be the bridge between the two departments and so need to have the cross-functional communication with Clinical Safety and Science teams

• You will be expected to write various reports or reviews and assessments and so need to complete them before the deadline with proper deadline management in a regulatory-driven environment

Requirements

Education: The MBBS or MD degree  from a recognised institution

Experience: Having demonstrated experience of about  0–5 years  in adverse event assessment and clinical narrative writing preferred; prior experience in a pharma or medical device company will give significant advantage.

Preference: Immediate joiner; pharmacovigilance experience is mandatory

Here are the two elaborated points in plain text:

Professional Environment: Working within a structured pharmacovigilance team at VIZEN means that you will be not operating in isolation but you will be a  part of a collaborative, process-driven environment where every case, signal, and report is handled with clinical rigour and regulatory precision. The nature of CRO work will  expose you to multiple therapeutic areas, at the same time will build diverse client pipelines, and varying regulatory market requirements simultaneously, which is something a single-sponsor role rarely offers.

Career Advancement: Pharmacovigilance is no longer a back-office compliance function  it is the centre of drug and device safety strategy globally. Developing deep expertise in ICSR medical review, signal detection methodology, and aggregate reporting places you at the intersection of clinical medicine and regulatory science,which makes you the  most in-demand in that  area across global pharma and device organisations today. As the regulatory agencies continue to raise the bar on post-market surveillance and benefit-risk documentation, professionals who can independently own these functions are increasingly more valuable not just locally but across US, EU, and APAC markets. The skills you build in this role position you for progression into senior medical reviewer.