Labcorp Drug Development

Specialist I Patient Safety, Romania

Location
Romania
Salary
Competitive
Posted
18 Jun 2021
Closes
13 Jul 2021
Ref
10024_67158
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Covance is looking for a Specialist I Patient Safety with C1 level of German language and working level of English language.

Please note that you would be working in shifts ( in the mornings, then in afternoons 2 week rotation).

Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
  • entry of safety data onto adverse event database(s) and tracking systems
  • review of adverse events for completeness, accuracy and appropriateness for expedited reporting
  • write patient narratives
  • code adverse events accurately using MedDRA
  • determine expectedness/listedness against appropriate label
  • identifies clinically significant information missing from initial reports and ensures its collection
  • ensure case receives appropriate medical review
  • prepare follow-up correspondence consulting the medical staff accordingly.
  • ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
  • reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines


  • Maintain a strong understanding of Covance's safety database conventions or client specific database conventions, as appropriate.
  • Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
  • Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events
  • Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
  • Work with Data Management or client on reconciliation of safety databases.
  • Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
  • Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.
  • Maintains a comprehensive understanding of Covance Safety's Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
  • Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.
  • Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
  • Build and maintain good PSS relationships across functional units.
  • Demonstrate role-specific Competencies on a consistent basis.
  • Demonstrate company Values on a consistent basis.
  • Begin to develop a good knowledge of contract assumptions; identifying out of scope work.
  • Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
  • Begin participating in Covance project teams and client meetings as appropriate.
  • Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
  • Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
  • Assist in the co-ordination of endpoint committees, as required.
  • Any other duties as assigned by management.
Education/Qualifications:
Required:

• German C1 language (certificate C1 for German language)

• English C1/B2 language

Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
Experience:
Required:
• High degree of accuracy with attention to detail.
• Functions as a team player.
• Good Communication.
• Knowledge of medical and drug terminology desirable.
• Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.
• Familiarity with ICH Guidelines
• Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
• Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
• Good written and verbal communication skills.
• Ability to work independently with moderate supervision.
• Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.