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Job Details

Drug Safety Specialist

Company: CROMSOURCE
Location: Belgium
Reference: HQ00001233
Closing Date: 23 Mar 18
Type: Temporary
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Job Title: Drug Safety Specialist   Location: Braine L'Alleud, Belgium   TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Drug Safety Specialist for one of our partner Biopharmaceutical Companies. This is a full-time temporary position with TalentSource, initially for 3 months with the possibility of extension. The successful candidate will be working on studies dedicated to one client.

Requirements:

Job Title: Drug Safety Specialist

Location: Braine L'Alleud, Belgium

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Drug Safety Specialist for one of our partner Biopharmaceutical Companies.

This is a full-time temporary position with TalentSource, initially for 3 months with the possibility of extension. The successful candidate will be working on studies dedicated to one client. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Main Job Tasks and Responsibilities:

  • Serves as subject matter expert on adverse event reporting and submission within patient safety and other cross functional areas
  • Leads the review and implementation of robust communication/interfacing processes with Pharmacovigilance outsourcing partners
  • Enhances overall Individual Case Safety Report (ICSR) system by implementing process improvements, working with other teams including but not limited to Quality Control team, safety physicians, local safety officers, and external vendors as needed.
  • Write and maintain SOPs regarding ICSRs. Provide insight and initiate any changes needed due to changing business need, system requirements, or regulatory changes
  • Be a point of contact for the safety case processing vendor, providing responses to queries and providing oversight on key processes.

Education and Experience:

  • Registered or licensed Nurse, Pharmacist or University Degree in life science with sufficient experience in case processing
  • 5 years of experience in the pharmaceutical industry with experience in pharmacovigilance department or a clinically-oriented discipline, including experience in the conduct of clinical studies and/or experience in the compilation or the analysis of aggregate safety data.
  • Knowledge of pharmacovigilance theory, regulations, the drug development cycle and application and of safety systems (Argus)

Skills:

  • Experience of working in teams and matrix organizations
  • Ability to apply knowledge gained from problem solving
  • Good interpersonal, verbal, and written communication skills in English
  • Detail-orientated with ability to multi-task.
  • Excellent communication, time management and organisational skills.

Our benefits when working via TalentSource Life Sciences in Belgium

  • Dedicated Line Manager
  • Employee satisfaction survey - your feedback is important for continuous improvement
  • Annual appraisals development planning
  • Yearly team event
  • New Year's diner
  • Group- and Hospitalisation insurance
  • Electronic meal vouchers
  • Internet reimbursement
  • Company mobile phone
  • Car with fuel card

If you have the experience needed for this position, please contact Laura Guascone, Consultant TalentSource Life Sciences Unit, and send your CV in WORD format to Laura.Guascone@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.

Keywords - Pharma, Pharmaceutical, Contracts, Contract, CRO, Contract Research Organisation, Drug Safety Specialist, Drug Safety, Pharmacovigilance, SDEA, Safety Data Exchange Agreements, Conduct of Clinical Studies, Safety System, Argus, Outsourced, Temporary, Freelance, Contract, ICSR, Individual Case Safety Report, PV

Drug Safety Scientist

Apply for this job: Drug Safety 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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