Tech People is a European provider of technical skills permanent recruitment and temporary contracting services for multiple industries.
Our client is a multinational company that is, among other activities, providing their clients with IT solutions on many fields.
We are now searching for a:
SAFETY SURVEILLANCE (JT)
- 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.
- Fluency in English
- Medical degree (MBBS or equivalent and above) with more than 1 year of
- Pharmacovigilance experience in Pharmaceutical Company or Contract Research Organization (CRO) including safety surveillance or signal detection activities.
How to apply/ contact information:
Place of work: Budapest/Hungary
Please send your CV online in English or contact for details.