Drug Safety Associate

Responsibilities: - Receive and process adverse event reports from various sources, including healthcare professionals, consumers, and clinical trials. - Conduct initial assessment of reported adverse events to determine seriousness, expectedness, and causality. - Enter adverse event data into safety databases accurately and in a timely manner, ensuring...

Summarized Purpose: Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Activities include but are not limited to delivery...

**Regulatory Affairs Associate** - Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. - Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory...

The Pharmacovigilance Information Specialist (PVIS) for GPIO (Global Pharmacovigilance Information Office) will research, review, and maintain information related to expedited and periodic safety reporting requirements for both clinical trial studies and post market projects. The PVIS works to ensure company and client compliance with relevant national and...

Job Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United...

**Job Summary**: The Pharmacovigilance Associate plays a key role in monitoring and ensuring the safety of pharmaceutical products throughout their lifecycle. Working within a multidisciplinary team, the associate is responsible for the collection, assessment, and reporting of adverse events and safety information associated with medicinal products. This...

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and...

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing**: Serve as a Clinical Data reviewer and identify any errors in data by...

Regulatory Affairs Consultant.8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute...

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and...

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and...

Shared INN PSR management - Provides Global PSR format training to new and contributors, provides mentorship for new PREs; - SME in inspections, internal and partner audits to communicate PSR processes and expectations as defined in quality documents; - Implements process and quality document changes when regulatory requirements change or process...

Sphera is a leading global provider of enterprise software and services that enables companies to manage and optimize their environmental, health, safety and sustainability. Our mission is to create a safer, more sustainable and productive world. Sphera is a portfolio company of Blackstone, a U.S.based alternative asset investment company that focuses on...

Hyderabad **EMAIL** I **Career opportunity** **Consultant - Medical Device Regulatory and Clinical Affairs** **Project Associate - Remote, India** Diagnostics compliance with international regulatory requirements. We serve clients with hands-on support for compliance with applicable regulatory requirements of our clients’ target markets. Our...

**Description** **Principal Biostatistician** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...

Exp : 4 to 5 yrsLocation : Pune hybrid/ REMOTE (In case of Remote candidate can be asked to visit the Pune office once in a month if required only)NP : Immediate to 10 daysJob Description : QA testing with experience on SFDC platform and data testingRequired Skills : QA testing, SFDC , data testingQuality assurance testers are primarily responsible for...

Exp : 4 to 5 yrsLocation : Pune hybrid/ REMOTE (In case of Remote candidate can be asked to visit the Pune office once in a month if required only)NP : Immediate to 10 daysJob Description : QA testing with experience on SFDC platform and data testingRequired Skills : QA testing, SFDC , data testingQuality assurance testers are primarily responsible for...

Exp : 4 to 5 yrsLocation : Pune hybrid/ REMOTE (In case of Remote candidate can be asked to visit the Pune office once in a month if required only)NP : Immediate to 10 daysJob Description : QA testing with experience on SFDC platform and data testingRequired Skills : QA testing, SFDC , data testingQuality assurance testers are primarily responsible for...