Lead Safety Reporting Specialist

Lawrence Harvey

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Job ID :

10159


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

Western Europe,--Dusseldorf,Düsseldorf,


Key Skills :

Safety, repoting, cra,pharmaceutical, monitoring


Salary :

Negotiable


Date Posted :

19 Jan, 2018



Company Name :

Lawrence Harvey


Location1 :

Düsseldorf




Job Category :

Pharma Research & Development Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

* Represent the GCO Safety Unit in audits and provide support during inspections
* Ensure that systems used by the GCO Safety Unit for outbound safety reporting are up-to-date and validated
* Ensure that processes are documented and reviewed
* Ensure reconciliation and compliance monitoring activities
* Monitor and ensure adherence to global regulatory requirements and relevant procedures
* Act as key contact for various stakeholders related to outbound safety reporting
* Support clinical trial teams with the set-up of compounds and trials in the safety reporting systems used by the GCO Safety Unit for the distribution of outbound safety reports
* Provide guidance and training to the clinical trial teams related to outbound safety reporting processes
* Implement Service Agreements with local operating companies
Your profile
* University degree (preferably life sciences)
* At least 3 years' experience in the Pharmaceutical Industry, with at least 2 years' experience in safety reporting or clinical research
* Demonstrated strong organizational, interpersonal and communication skills and experience of working in cross-functional teams, in an international environment
* Effective decision-making and problem-solving skills, in order to address safety and compliance issues in a timely manner
* Understanding of the broader impact and possible implications of safety and compliance issues
* Ability to work accurately to tight timelines
* Excellent German and English language skills (written and spoken)
* Excellent computer skills, MS Office Suite, ideally knowledge of system life-cycle management and validation


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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