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Patient Safety Associate


Tata Consultancy services is one of the largest Multinational company providing services to their client in Business & IT . You will be part of the Pharma department at TCS and responsible for drug safety project. To support one of our long standing client’s requirement in Drug Safety we are recruiting for various position in Drug Safety/Pharmacovigilance in Budapest.
This role will be

  • 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.

Are you interested in pharmacology and working in a professional and friendly environment while handling cases that contribute to health safety?

If you are read on, we might have a great opportunity for you! Our team is looking for someone who can work independently as well as in a team. And if you find beauty in being organized and developing your work to master`s level by giving your best performance day by day, do not hesitate to apply!


As a Patient Safety Associate you will be required to perform tasks as it follows:

  • 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.
  • 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 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 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 trainings 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.


You will be successful in this role if you have:

  • 0-2 years of PV Case Processing experience.
  • Excellent spoken and written English.
  • Graduate in Pharmacy or Life-Science.
  • Ability to evaluate, interpret and synthesize scientific data (analytical thinking)


· 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.


· 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.

General work performance:

· 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.



In our Shared Service Center you can taste the world by working together with more than 90 nationalities. As part of the Tata Group, India’s largest multinational business group, TCS has over 450,000 of the world’s best-trained consultants in 46 countries.

This position belongs to the BPS (Business Process Solutions) unit. This unit is helping enterprises achieve significant and sustained business outcomes by leveraging our deep domain expertise and operations.

As a future TCSer, you will be provided with:

  • A career path that will allow you to become a Subject Matter Expert
  • The opportunity to work on different Finance and Accounting (F&A) management processes across different industries
  • Get trained on various competencies and skills
  • A great diversity of cultures
  • Language courses and training
  • On-site relax & gym rooms
  • Volunteering, sport and employee events


Andrea Ignatakova



Andrea Ignatakova