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Job Details

Safety Specialist II, Poland

Company: Syneos Health
Location: Warsaw
Reference: 18004216
Closing Date: 07 Jun 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Syneos Health in Poland is now looking to hire Safety Specialist in Warsaw! Learn more about our new opportunity by clicking this link and let's discuss.

Requirements:

Safety Specialist II

Poland

Office-based in Warsaw

Permanent contract

 

Main responsibilities include

  • Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance; assists in the design and implementation of safety collection, processing, and reporting systems.
  • 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
    • Develops and reviews project proposals, agreements, invoices, financial measures, and performance metrics; performs limited budget review under supervision.
    • Coordinates workload /workflow and status reviews.
  • Manages systems for receipt and tracking AE/endpoint information.
  • Processes AEs/Endpoints according to SOPs specific safety plans.
    • Triages AEs, evaluates AE data for completeness, accuracy, and regulatory reportability.
    • Enters data into safety/adjudication database.
    • Performs Quality Control (QC) of entered data/endpoint dossiers.
    • Codes events, medical history, concomitant medications, and tests.
    • Compiles complete narrative summaries.
    • Participates in generation of reports to the sponsor and regulatory authorities;
    • Coordinates with data management staff
  • 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.

 

Eligibility/Qualifications/Requirements

The ideal candidate will need the following experience / skills to be considered:

  • BA/BS in Life Science or Registered Nurse/Pharmacist.
  • Minimum 1 year experience in Safety and Pharmacovigilance
  • Knowledge of reporting timelines is required.
  • 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.

 

We have a comprehensive benefits package and offer highly competitive remuneration.


If you have the required experience for this position and are eligible to work in the required location then please apply by CV.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/

Please be advised only selected candidates will be contacted back.

 

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world

Apply for this job: Safety Specialist II, Poland

Contact Information:

Address:  Poland (Polska)
Ul. Nowogrodzka 68 02-014 Warsaw (Warszawa)

Poland
Website:  Visit Our Web Site

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