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Patient Safety Associate

Introduction

Case handler who

Ø completed the basic PharmacoVigilance and the required case handling trainings;

Ø before sign off, perform the initial phase of the case handling process;

Ø after sign off, perform end-to end case processing and close cases independently in the safety database for cases that require minimal data to be entered (category A cases in PMS/CT, category B cases in PMS).

Patient Safety Associate can act as a Mailbox handler or Mailbox handler backup.


Function

Area of responsibility:

Ø Ensure completion of basic training and team specific trainings (on category A (and B) cases) in case handling.

Note: There is no B category in the Clinical Trial process.

Ø Begin and complete the process for competency sign off on category A (and B) cases.

Ø Before sign off, perform the initial phase of the case handling process, including the triage activity and uploading adverse event source documents into the safety database.

Ø After sign off, enter initial and follow-up information for adverse event case reports of category A (and B) cases into the safety database, using data interpretation, coding and writing skills in accordance with the effective process instructions, SOPs and OPIs to ensure data consistency and compliance to high data quality standards.

Ø Ensure compliance to client and TCS procedural documents and policies.

Ø Perform all activities within the required timeframes to ensure regulatory compliance.

Ø Collaborate with Medical Advisors with regards to adverse event capturing, seriousness or company causality assessment.

Ø Raise and manage safety queries within the required timeframe.

Ø Support a performance-driven culture.

Ø The Case handler can be nominated for:

o Legal case handling training after completion of the basic training and team specific trainings and at the discretion of the Team Leader;

o category C case handling training or Literature case handling training after the sign off and at the discretion of the Team Leader.

o Person filling the position shall perform any other task given by her/his supervisor, which belongs to this position by its nature or her/his experience or education meets the requirements to perform.


Requirements

Ø Academic Qualification:

· Qualified to degree level in biosciences or an appropriate healthcare or pharmaceutical industry background.

Ø Experience:

· Drug Safety/Pharmacovigilance experience and an understanding of regulatory requirements for the collection, management and reporting of individual case safety reports (ICSRs) is an advantage.

Ø Technical:

· An ability to understand the principles and concepts associated with Patient Safety case-handling process, including regulatory requirements for ICSR reporting.

· Basic competence with medical terminology.

· Computer literacy.

Ø Others:

· Able to work independently, guided by procedures, with appropriate support.

· Able to work effectively as part of a team.

· Attention to details.

· Excellent interpersonal and communication skills.

· Ability to prioritize, schedule and organize.

· Good time management.


Information

Elena Berlingeri +36 1 886 8000

Application

Elena Berlingeri +36 1 886 8000