26 December 2008

Team Lead- Drugs Safety/Pharmacovigilence in Tcs,Mumbai.

Job Designation: Team Lead in Drugs Safety/Pharmacovigilence.

Job Description:
 Overall in-charge of day-to-day activities for sub-process in Pharmacovigilance/Drug Safety
 Provide technical expertise to Pharmacovigilance/Drug Safety team
 Direct reports development in identifying training needs
 Oversight of direct reports activities
 Manage and coordinate across Pharmacovigilance/Drug Safety sub-processes (Client specific)
 Provide regular status reports on budget recognition of projects to Project Managers
 Ensure compliance to SOPs
 Perform tasks/activities as communicated by the Project Manager.
 Documentation of all project related activities
 Assist in developing and implementing new techniques in Pharmacovigilance/Drug
Safety activities
 Develops strategies in co-ordination with Team leads and Project Managers so as to meet quality requirements efficiently and meet timelines set by the client.
 The operational techniques and activities undertaken within the Pharmacovigilance/Drug Safety Unit
 Roche Pharmacovigilance/Drug Safety SOPs and other standards
 Undertake training related to a project to Pharmacovigilance/Drug Safety team members.
 Escalation of identified unresolved issues to project manager on time
 Ensure that projects are completed within budget constraints and as per agreed timelines
 Ensure adequate resource of the project throughout its lifecycle
 Ensure appropriate distribution of work among direct reports
 Resignations / Absconder communication to the project manager
 Provide annual performance appraisals of direct reports and provide regular feedback, if applicable to Operation Manager (During Appraisal / whenever asked for)
Act as a gatekeeper for the changes requested to product, service or process (client specific)

Requirments: Solid experience and understanding of ICH GCP principles, clinical drug development process, organizational, strategic, communication and inter-personnel skills

Contact
Shilpa Sharma
Maven Workforce (P) Ltd
New Delhi
Ph:91-11-45682211, 09811445389

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