Safety Associate II

Company
Synteract
Location
Poland
Salary
Competitive
Posted
09 Feb 2021
Closes
11 Mar 2021
Ref
28914
Discipline
R & D
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Safety Surveillance Associate II - Warsaw, Poland

Office based or remote based

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. With our mission of Bringing clinical trials to life TM , we provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

The Safety Surveillance Associate II is responsible for the receipt, tracking, and processing of safety reports from clinical trials, spontaneous reporters, and other entities, as applicable, according to the Company's procedures and global drug and device safety regulations and guidelines. May act as the Safety Lead for client study(ies)/project(s).

Specific tasks would include:
  • Reviews and analyzes safety report information for completeness, accuracy and regulatory reportability requirements.
  • May provide back up for Safety Inbox tasks as needed.
  • Evaluates safety case data with an emphasis on medical presentation; may conduct discussions regarding specific patient case data with health care practitioners and Sponsors; contributes to determination of regulatory reporting requirements based upon case data, product information, and ICH, FDA, and country specific guidelines and regulations.
  • Prepares safety reports, including preparation of narrative summary within specified project, regulatory, and/or key performance indicator (KPI) timelines.
  • Identifies missing/discrepant data (medical and documentation issues), writes queries, addresses queries with site personnel, evaluates query responses, and resolves queries when complete.
  • May contribute to configuration specifications of the safety database, including updates.
  • Performs coding of adverse event and medical history terms, concomitant medications, and laboratory test names within the safety database.
  • Performs clinical review of data from the Case Report Forms with an emphasis on safety.
  • Reviews safety information/tables and/or reports for clients and/or regulatory agencies.
  • Reconciles safety data with applicable sources.
  • With guidance, may contribute to CRF design, Safety Management Plan, and project related document generation.
  • May participate in audit preparation activities.
  • May participate in client and project team meetings, as applicable.
  • Provides operational and technical guidance and direction to colleagues.

Qualifications:
  • Bachelor's degree in nursing (B.S.N.), Registered Nurse (R.N.), Doctor of Pharmacy, Health Science degree or other related field of study and 2+ years' safety surveillance experience or equivalent combination of education and experience.
  • Comprehensive knowledge of medical terminology and of GCPs, ICH guidelines, and global drug safety and clinical trial regulations.
  • Intermediate level proficiency in Microsoft Word, Excel and Outlook; basic proficiency in PowerPoint.
  • The ability to learn Safety database software and related software functionality.
  • Effective verbal and writing skills; English + local language, if relevant.


If you're passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.

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