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Job Details

Lead Safety Reporting Specialist

Company: CROMSOURCE
Location: Germany
Reference: HQ00001198
Closing Date: 20 Mar 18
Type: Contract
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Description   Job Title: Lead Safety Reporting Specialist Location: Neuss, Germany   TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Lead Safety Reporting Specialist to strengthen the team of one of our TOP Pharmaceutical client Companies in Breda, Netherlands.   Main Job Tasks and Responsibilities   · Represent the GCO Safety Unit in audits and provide support during...

Requirements:

Description

Job Title: Lead Safety Reporting Specialist

Location: Neuss, Germany

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Lead Safety Reporting Specialist to strengthen the team of one of our TOP Pharmaceutical client Companies in Breda, Netherlands.

Main Job Tasks and Responsibilities

· 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

Education and Experience

· 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

If you have the experience needed for this position, please contact Alexander Sourounis, Senior Consultant TalentSource Life Sciences Unit, and send your CV in WORD format to alexander.sourounis@cromsource.com

Why TalentSource Life Sciences/Cromsource

CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Drug Safety Associate

Apply for this job: Lead Safety Reporting Specialist

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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