pharmacovigilance Team Lead at Tata Consultancy Services

pharmacovigilance Team Lead

Tata Consultancy Services

Job description

role :clinical operations/ etmf

location: mumbai/ bangalore/ pune

job role: ensure the tmf documents are filed and finalized to meet the required timelines as per study plan and document any deviations if any. keep the tmf inspection ready and in alignment with the study agreed strategy and applicable milestones. generate the tmf completeness metrics, track performance and liaison with relevant stakeholders for closure of actions if any. conduct analysis and identification of business problems/opportunities that may arise and support the implementation of high quality solutions. understand all aspects of the etmf system and associated tools. conduct regular teleconference with the client study teams and management and communicate related issues

role: pv team lead

location: mumbai/ pune

job role: overall accountability of day-to-day case processing activities including service level agreement monitoring and focusing on compliance. ensuring adequate resource… availability in drug safety teams to support drug safety activities. proactively identifying trends in compliance and proposing solutions to case processing and resourcing issues. supports in the resolution of questions related to late icsrs. ensuring that special coaching or training is provided on any topic required by any pv scientist to ensure that the individuals are appropriately trained for their role.