Patient Safety Associate | Budapest, Hungary

Description Enter reports of drug side-effects from post-marketed or clinical study sources to the safety database. Handle non-serious and serious cases according to regulatory requirements, process instructions, and standard operational procedures. Resolve queries related to pharmacovigilance activities and individual case reports. Working hours Monday to Friday, 09:00am - 6:00pm Responsibilities

• Ensure completion of basic training and team-specific training (on category A (and B) cases) in case handling.
  Note: There is no B category in the Clinical Trial process.
• Begin and complete the process for competency sign off on category A (and B) cases.
• 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.
• After the 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.
• Ensure compliance to the client and TCS procedural documents and policies.
• Perform all activities within the required timeframes to ensure regulatory compliance.
• Collaborate with Medical Advisors with regards to adverse event capturing, seriousness, or company causality assessment.
• Raise and manage safety queries within the required timeframe.
• Support a performance-driven culture.
• The Case handler can be nominated for:
• Legal case handling training after completion of the basic training and team-specific training and at the discretion of the Team Leader;
• category C case handling training or Literature case handling training after the sign-off and at the discretion of the Team Leader;
• 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.

Backgrounds

• Biology
• Biomedical Science

Skills

• Communication
• Data Management
• Analytical thinking
• Data Analytics

Languages

• English

  Minimum study level

• Bachelor (Required)

Slot
1 Jun 2021 - 1 Jun 2022


Other information

• Salary: 220000 HUF per month
• Fee: 259EUR(only if you are accepted)
• A Computer will be provided
• Accommodation and Transportation it's not included 
• You will be Certified as a Global Talent Participant
• AIESEC will provide you support such as: application support, arrival pickup, accommodation support, leadership development seminar and cultural integration activities.

Once you make the application an AIESEC representative will contact you via phone as soon as possible and provide to you more information and guidance. Please make sure to check your inbox or spam mail in for the next 3 days after your application.