This job offer is not available in your country.

Junior Drug Safety Associate

ConfidentialBengaluru / Bangalore

27 days ago

Job description

Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines

Monitor and download ICSRs from Eudravigilance (EV) for valid ICSRs

Processing literature, spontaneous as well as clinical trial and solicited cases

Schedule and perform search of literature reports for valid ICSR in PubMed and MLM

Responsible for generation of reports and submission to health authority and business partners

Ensure data entry of serious and non-serious ICSRs (Spontaneous, Solicited and literature) in ARGUS as per client SOP and WI with high level of data accuracy

Responsible for coding events, indications and patient history based on MEDDRA

Coding of suspect products as well as concomitant., Amending the narrative when required, Performing Labeling of events

Responsible to obtain follow-up information for all serious and non-serious cases as per the guideline on Good Pharmacovigilance Practices (EU-GVP).

Perform the submission of the processed cases to regulatory authority and report distribution to Partner.

Communicate and interact effectively within and across all client key stakeholders and within internal team management as appropriate

Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines

Track and perform daily and monthly reconciliation of ICSRs as per client requirements

Skills Required

Report Generation

Create a job alert for this search

Junior Associate • Bengaluru / Bangalore

Related jobs

Promoted

Regulatory Affairs Excellence Specialist

PhilipsBengaluru, Karnataka, India

Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organiza...Show moreLast updated: 15 days ago

Promoted

Medical Auditor

XpertDoxhosur, tamil nadu, in

Check the result of the automated coding solution and provide feedback regarding error in the AI engine.Submit the generated report through post-auditing within the 24-hr TAT.Improve the automated ...Show moreLast updated: 23 days ago

Promoted

HCM technical +Fast formula+HCM extract

Best Infosystems Ltd.hosur, tamil nadu, in

HCM technical +Fast formula+HCM extract_Contract (One Year)_Pan India(Remote).HCM technical +Fast formula+HCM extract.Functional knowledge of Compensation and Equity area in Oracle is plus.HCM Tech...Show moreLast updated: 30+ days ago

Promoted

Regulatory Affairs Associate III

ConfidentialBengaluru / Bangalore, India

Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countr...Show moreLast updated: 25 days ago

Promoted

Safety Analyst-Bengaluru, India

ConfidentialBengaluru / Bangalore, India

Diversified is a global leader in audio visual and media innovation, recognized for designing and building the world's most experiential environments. Our award-winning team specializes in deliverin...Show moreLast updated: 25 days ago

Promoted

Group Manager - Transactional Quality ( AML / KYC / FinCrime) - Bangalore

WNSBangalore Urban, Karnataka, India

Follow banking regulations & guidelines.Liaise with regulatory, legal and banking regulation as per requirement.Ensure that daily, weekly and monthly tick lists are effectively maintained and the c...Show moreLast updated: 23 days ago

Promoted

Senior Medical Safety Advisor

IQVIAbangalore district, karnataka, in

Pharmacovigilance / PV Experience.The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance pr...Show moreLast updated: 30+ days ago

Promoted

Technical Safety Consultant

ConfidentialBengaluru / Bangalore, India

This job is with ABB, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.At ABB, we help indu...Show moreLast updated: 25 days ago

Promoted

Unit-Level Traceability Technical Expert – OSAT

Tata ElectronicsKolar, Karnataka, India

Tata Electronics (a wholly owned subsidiary of Tata Sons Pvt.India’s first AI-enabled state-of-the-art Semiconductor Foundry. This facility will produce chips for applications such as power manageme...Show moreLast updated: 23 days ago

Promoted

Unit-Level Traceability Technical Expert - OSAT

Tata ElectronicsKolar, Karnataka, India

Promoted

Validation Lead

Compliance Group Inchosur, tamil nadu, in

We are looking for Validation Lead for Compliance Group Inc.High preference to short notice period.Develop and implement validation strategies and processes to ensure the quality and reliability of...Show moreLast updated: 30+ days ago

Promoted

Regulatory Compliance Specialist -2+

Jupiter AI LabsBangalore, IN

Regulatory & Compliance Specialist.India and international destination countries.This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related ...Show moreLast updated: 15 days ago

Promoted

Regulatory Affairs Specialist

Biocon BiologicsBengaluru, Karnataka, India

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.Developme...Show moreLast updated: 30+ days ago

Promoted
New!

Senior Regulatory Affairs Specialist

Classic Search Private LimitedBengaluru, Karnataka, India

Role - Team Lead - International Regulatory Affairs Location - Bangalore Industry - Pharmaceutical Required Experience : - 10-15 years Education : - M. Sc Must have experience in IRA handling regula...Show moreLast updated: 4 hours ago

Promoted

HILS Validation

ConfidentialBengaluru / Bangalore

Please apply only if you are available on Saturday, 1st Feb for a 30 mins virtual interview.We are looking for immediate up to max 45 days notice period candidates. Automotive protocols CAN / LIN / Ethe...Show moreLast updated: 27 days ago

Promoted

EHS Specialist

ConfidentialBengaluru / Bangalore, India

The role is responsible for working with the Site EHS Leader to develop and deploy Environmental Health & Safety programs & policies to mitigate risk, drive regulatory compliance and establish a po...Show moreLast updated: 25 days ago

Promoted

Fiserv DNA Tester

ConfidentialBengaluru / Bangalore

Minimum of 5 years of experience as a QA -professional in the banking sector, ideally with a focus on lending and experience in developing and managing various loan products.Practical experience wi...Show moreLast updated: 30+ days ago

Promoted

Regulatory Affairs Executive

Halma plcBengaluru, Karnataka, India

Halma is a global group of life-saving technology companies, driven by a clear purpose.We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs...Show moreLast updated: 30+ days ago