Associate, Medical Safety Operations

Lawrence Harvey


Job ID :

9454


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

North America,--California,California,


Key Skills :

Associate, Medical Safety Operations


Salary :

Negotiable


Date Posted :

13 Nov, 2017



Company Name :

Lawrence Harvey


Location1 :

California




Job Category :

Drug Safety Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

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


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


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 www.lawrenceharvey.com.

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