Drug Safety Associate

Overview

Vizen Life Sciences is seeking a Drug Safety Associate to join their  pharmacovigilance team. This is the I role where you will be expected to perform the  processing, evaluation, and reporting of adverse event cases that take place  in compliance with global regulatory requirements. Your  work involves working, across the full lifecycle of individual case safety reports (ICSRs), ensuring timely and accurate submission to health authorities.

Key Responsibilities

• Case intake & processing: As soon as you receive you  enter adverse event reports from spontaneous sources, clinical trials, literature, and solicited programs into the safety database

• Case assessment: The data that you will receive then will be evaluated by each ICSR for seriousness, expectedness, and causality in accordance with ICH E2A guidelines and the  applicable SOPs that come in the compliance.

• Regulatory submission: After the data is stored and evaluated you will prepare and submit the expedited and periodic safety reports to health authorities within specified timelines of 7 to 15 days of reporting.

• Follow-up & query management:Always  initiate and track follow-up queries with reporters, healthcare professionals, and internal teams to ensure that the documentation is complete and medically accurate for each case scenario.

• Signal support:  You will provide assistance  in all the ongoing signal detection and monitoring activities,at the same time  contribute in data and case-level analysis in order to signal the management process.

• Quality & compliance:One of the most crucial responsibilities is to ensure  that all case handling adheres are done according to the  internal quality standards, regulatory guidelines of EMA, FDA, ICH, and they  meet the  agreed timelines with zero critical deviations.

Required Skills

• Argus Data Base — Having demonstrated experience on Argus Data base is mandatory

• Need  to have the deep knowledge of adverse event assessment & management

• Thorough the ICH E2A / E2B guidelines  to ensure that the compliance is followed properly.

• Ability to write clear, precise and medically accurate clinical narratives.

• Being able to complete the work before deadline with proper deadline management in a regulatory environment

• You will be the intersection of many different departments and so need to have cross-functional coordination

Qualifications:

Education: The required minimum degree is  B. Pharm / M. Pharm / Pharm D from a recognised institution

Experience: Need to have  1–8 years in pharmacovigilance; experience on Argus Data Base is mandatory

Preference: Immediate joiner; pharmacovigilance experience is mandatory

Benefits

Professional Environment:

Working within a structured pharmacovigilance team at VIZEN means you will be not operating in isolation ,you will be the  part of a collaborative, process-driven environment where every case, signal, and report is handled with clinical rigour and regulatory precision. The day-to-day work of CRO  exposes you to multiple therapeutic areas, creates diverse client pipelines, and varying regulatory market requirements simultaneously, which is something a single-sponsor role rarely offers. The professional work ethics and the experience that the team holds will definitely benefit you to build a great professional career in this domain.

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 drug safety will make you the most in-demand in the  areas across global pharma and device organisations today. As regulatory agencies continue to raise the bar on post-market surveillance and benefit-risk documentation, professionals who can independently own these functions are increasingly sought after  not just locally but across US, EU, and APAC markets. The skills you build in this role position you for progression into senior drug safety, signal lead, aggregate report author, or PV management tracks, giving you a clear and well-supported path for long-term career growth.