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Safety Surveillance Physician Fixed-Term

Introduction

Are you a Medical Doctor? Do you have Pharmacovigilance experience in Pharmaceutical Company or Contract Research Organization ?

If you are, read on, we have a great opportunity for you to support one of the world’s most prestigious pharma companies. You will be part of a 100+ multicultural team, working to help create a new drug that helps humankind live freely.. We are recruiting for a new project in Pharmacovigillance, which is a relatively new business area in Hungary; this will be a great chance for you to become more competitive on the job market after this one year project. We want to help you develop your career in a global environment while contributing to health safety.


Function

  • To ensure compliance with global and local procedural documents and local implementation of client and TCS Patient Safety objectives, policies, procedures and processes.
  • To maintain up to date knowledge of the client products assigned with focus on the safety perspective. This includes but is not limited to pharmacology, indications, safety and efficacy aspects and could potentially include clinical studies and epidemiological analyses.
  • To review client safety surveillance plan and changes made in it, if any.
  • To review aggregate case reports from client designated safety database & other sources as applicable, using relevant client designated safety surveillance tool
  • To conduct initial evaluation of safety signals from routine review of cumulative safety data and document outcome according to client specified criteria and requirements
  • To document potential signal and related information as per client specified criteria & requirements and maintain surveillance action log up to date.
  • To notify client surveillance team of any safety signal that it has detected that may require urgent evaluation and action.
  • To conduct further evaluation of safety signal as required by client, if applicable
  • To prepare, summarize, evaluate and document routine pre-SIRC (Safety Information Review Committee) safety outputs, if applicable
  • To participate in routine and ad-hoc team and project related meetings between client and TCS like Handover Meeting, Surveillance Meeting, and Safety Strategy & Management Team Meeting, as applicable.
  • To prepare training material, conduct and assess periodic and need based trainings as and when required
  • To provide ongoing training on the updated SSP, routine signal management requirements, product safety profiles and updated safety signal evaluation criteria for new hires.
  • To participate in conducting gap analysis, and identify the remedial actions for the improvement of quality of deliverables as and when required.
  • To provide regular work update to Team lead-safety surveillance.

Requirements

  • Medical degree (MBBS or equivalent and above) with more than 01 year of Pharmacovigilance experience in Pharmaceutical Company or Contract Research Organization (CRO) including safety surveillance or signal detection activities
  • Experience in diverse therapeutic areas is preferable
  • Knowledge of drug safety & clinical development and ICH/GCP principles

  • Good knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation
  • Good knowledge of global Pharmacovigilance regulatory requirements
  • Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions with client
  • Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
  • Candidate must be able to work in Hungary starting November

Offer

As our future TCSer

  • You will contribute to the development of a new drug so that our client can provide the best care for their customers
  • You will have opportunity to work with one of the Top 10 Pharma company partners
  • You can use your knowledge and skills in the area of Pharmacovigilance – Drug Safety (The branch of pharmacology focused on detecting, assessing, understanding and preventing long- and short-term adverse effects of medicines.), and its regulations
  • Home office.


Information

Application