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Job Details

Senior Safety Specialist - Central and Eastern Europe

Company: INC Research
Location: Central and Eastern Europe
Reference: 17003140
Closing Date: 26 Aug 17
Type: Permanent
Salary (£): Negotiable

Job Summary:

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life.


We are currently recruiting a Senior Safety Specialist to be located in one of the following countries: Poland, Ukraine, Russia, Hungary, Czech Republic, Slovakia, Bulgaria, Romania, Serbia. Israel

A summary of duties you will be involved in as a Senior Safety Specialist:

• Performs all aspects of the collection, processing, and reporting of adverse events/endpoints adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices
(GCPs), regulatory guidelines, and study procedures.
• Sets up/leads a safety program for an expanded access program, also known as early access, compassionate use, managed access, named patient programs and temporary authorization for use (ATU) programs
• Manages daily workload of Safety Specialists within the department with limited line management responsibilities.
• Mentors and trains junior Safety Specialists.
• Ensures that the project activities are completed in a timely manner with acceptable quality and acts as a decision maker.
• Supports business development activities and delivers presentations.




To succeed in this role you will need the following skills/experience:
• BA/BS in Life Science or Registered Nurse/Pharmacist.
• Moderate experience in Safety and Pharmacovigilance in Clinical Research Organization (CRO) with therapeutic specialties preferred.
•  Experience of setting up/leading a safety program for an expanded access, also known as early access, compassionate use, managed access, named patient programs and temporary authorization for use (ATU) programs preferred
• Knowledge of relevant international regulations/guidelines and strong understanding and usage of medical terminology preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet.
• Strong organizational, presentation, documentation, analytical, oral/ written (English), and interpersonal skills with strong judgment and tactful discretion appropriate to a professional medical setting.
• Ability to make effective decisions, manage multiple priorities, exhibit high degree of accuracy, and meet deadlines in a highly dynamic environment. Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.

What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.

Apply for this job: Senior Safety Specialist - Central and Eastern Europe

Contact Information:

Address:  INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
Tel:  +36 1 489 48 56
Website:  Visit Our Web Site

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