Associate, Medical Safety Operations

Lawrence Harvey

Sorry, This job post has expired.

Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

North America,--California,California,

Key Skills :

Associate, Medical Safety Operations

Salary :


Date Posted :

13 Nov, 2017

Company Name :

Lawrence Harvey

Location1 :


Job Category :

Drug Safety Jobs

Experience :


Job Type:


Travel Amount:



Essential Duties/ Responsibilities

* Performs internal activities and oversight of outsourced activities for individual case safety report (ICSR) processing and reporting from all sources in compliance and quality according to company procedures and regulatory requirements.
* Ensures that expedited and periodic safety reports to regulatory agencies and license partners are submitted and compliance is tracked.
* Liaises with assigned Clinical Reviewer to ensure that appropriate review and assessment is provided for ICSRs.
* Safety data extraction and production from MS systems for internal partners and regulatory submissions
* Performs receipt and submission reconciliation between license partners and vendors and serious adverse event (SAE) reconciliation between the clinical and safety databases.
* Collaborates with QA on product complaints associated with ICSRs.
* Supports regulatory agency interactions (both written and verbal), inspections, and audits.

If your experience and availablity matches the description, you are currently based in the United States, eledgiable to work in the united states and are set up to work Corp2Corp please apply.

Company Name:

Lawrence Harvey


150 Leadenhall Street,London


Staffing Firms


United Kingdom





100 - 499


Pharmaceutical Recruitment



Phone No. :

0203 327 3072

Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit

View all Lawrence Harvey Jobs

© 2018 Jobsinpharma - 4ward Technologies Ltd All rights reserved.