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Job Details

Safety Specialist II - CEE Countries

Company: INC Research
Location: CEE Countries
Reference: 17003889
Closing Date: 07 Oct 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 Safety Specialist II to be located in one of the following countries: Poland, Ukraine, Russia, Serbia, Bulgaria, Romania, Hungary, Czech Republic.

A summary of duties you will be involved in as a Safety Specialist II:
• 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.

• Assumes responsibilities of safety project leader/endpoint manager for projects which require a team of Safety Specialists including but not limited to:
- Assigns resources and timelines; reorganizes daily workload based on priority.
- Proactively communicates to management new issues and suggested solutions; reports availability to take on new assignments.
- Develops and reviews project proposals, agreements, invoices, financial measures, and performance metrics; performs limited budget review under supervision.
- Prepares Safety Management Plan.
- Coordinates workload /workflow and status reviews.

• Generates reports to clients and regulatory authorities as needed
• Assists in preparation and distribution of all required periodic reports for both clinical and post-marketing projects.
• Assists training of Investigators and other departments on AE reporting/adjudication
• Delivers presentations regarding safety and pharmacovigilance to internal and external customers




To succeed in this role you will need the following skills/experience:
• BA/BS in Life Science or Registered Nurse/Pharmacist.
• Nominal experience in Safety and Pharmacovigilance
• Clinical Research Organization (CRO) experience with therapeutic specialties 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: Safety Specialist II - CEE Countries

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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