INTRODUCTION

As a Patient Safety Associate you will be responsible or providing effective service on behalf of TCS to a client pharma company, helping them comply with pharmacovigilance regulatory responsibility of Individual Case Safety reporting.

FUNCTION

• Follow process steps as defined per SOPs for the assigned area of activities.
• Ensure compliance with global and local procedural documents and local implementation of client and TCS policies, processes and procedures
• Perform all activities within the required timeframes to ensure regulatory compliance
• Meet Key Performance Indicators, such as Productivity, Quality and Turnaround Time related
• metrics, as well as other requirements and goals as defined by the Direct Line Manager through the goal setting process according to TCS’s Performance Management System.
• Ensure, that the activities performed are accurately tracked with the related tools provided.
• Adhere to the defined shift timings and other company policies as per the TATA Code of Conduct, Integrated Quality Management System, TCS Hungary policies and any other guidelines applicable.
• Ensure completion of basic PV training in case handling.
• Begin and complete the process for competency sign off on non serious cases.
• Ensure that the case is QREd before closure in case the team member is not signed off on serious cases.
• Ensure structured data entry of non-serious adverse events onto client’s global PV safety database according to project specific SOPS and User Manual.
• Ensure completion of basic PV training in case handling.
• Begin and complete the process for competency sign off on serious cases.
• Perform quality check before closure of cases where other team member are not signed off on serious cases.
• Ensure structured data entry of serious and non-serious adverse events onto client’s global PV safety database according to project specific SOPS and User Manual.
• Prioritize the workload according to requests from internal and external stakeholders.
• Collaborate closely with the team and ensure professional interaction with contact persons from customer side as needed.
• Have a proactive approach towards identifying possible process improvement opportunities and
• address these ideas on the relevant forums.

REQUIREMENTS

• Degree in a Life Science related discipline (Qualified to degree level in life sciences or an appropriate healthcare or pharmaceutical industry background)
• 0 – 2 years of relevant experience
• Able to work independently, guided by procedures, with appropriate support
• Computer literate

OFFER

• TCS has been delivering services from Hungary since 2001, making us a perfect choice if you’re looking for stability.
• We provide a wide range of benefits, including a market leading comprehensive private health care package.
• We offer extensive self-development opportunities: our colleagues have a multitude of training possibilities for personal and professional growth.
• At TCS Hungary there are both vertical and horizontal career options for those who like to challenge themselves and try out different areas and positions.
• You will be part of a global and diverse working environment with relaxation areas, terraces, and a friendly atmosphere.
• You can seize the day with us at our company events, hobby clubs, and sporting initiatives.
• An attractive compensation package.

CONTACT INFO

Dr. Noemi Farkas-Hussey
Email address: noemi.farkashussey@tcs.com