CRO manager

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Job ID	122558BR
Position Title	CRO Manager
Division	Pharma
Business Unit	Pharma - Global Development
Country	India
Work Location	Hyderabad
Company/Legal Entity	Nov Hltcr Shared Services Ind
Functional Area	Development & Medical
Job Type	Full Time
Employment Type	Regular
Job Description	Managing interaction with external vendor/Partner/CRO in the operational and logistical aspects of drug safety operations according to relevant local and /or global pharmacovigilance standards, Novartis procedures and ensure that all assignments/ projects are completed with quality standards/KPIs met and essential documentation is managed. Efficiently manage contracted Pharmacovigilance services outsourced to KPO/CRO/ Partners in accordance to Novartis standards and/or policies and the given regulatory requirements. This includes facilitation and interaction with external and internal stakeholders to ensure SLAs are consistently met and regulatory compliance is maintained. Contribute to effective transition, knowledge transfer and steady-state delivery of the assigned scope of services to the partner/ CRO/ vendor through documentation, periodic performance reviews and alignment of the operational objectives between the two parties. Facilitate and manage effective communication at different functional and operational levels within the two partner organizations for accuracy, completeness and integrity of safety reports. Design and implement the vendor/partner performance management tools and systems in consultation with the different stakeholders from both the partner organizations including Technical, QA, IT, Procurement, Finance and others. Periodic tracking, measurement and monitoring of outsourced scope of services (eg: ICSR processing, aggregate reporting) and ensuring the contractual obligations are met consistently. Facilitate and manage the interactions between the leadership teams in both organizations including planning the periodic steering committee/ joint operational effectiveness meetings, coordinate for logistics, follow-up on the actions originating from such meetings/routine interactions. Act as a liaison between the functional and operational teams for exchange of ideas/ proposals/ target assignments for their completion and logical conclusion to achieve highest efficiency, productivity and compliance in safety information reporting (ICSR, Aggregate Reports) for Novartis. Leverage the resources and expertise from both the organizations for the betterment of submissions/results and further continuous improvement. Help and support the partner organization with forecasting on projects, planning, transition and assessment of performance/compliance risks to put mitigation plans together. Coordinate and support the partner organization during audits and inspections for logistics, documentation, CAPAs and corresponding audit compliance with closure of findings (if any), alert the Novartis management of pending compliance issues, audit findings at partner site, garner support from internal Novartis sectors/departments for prevention and/or closure of compliance observations/findings.
Minimum requirements	Minimum : A Life Sciences degree (for graduates) or equivalent qualification with over 5 years of work experience in pharmacovigilance or drug development. Vendor Management experience would be preferred Good knowledge/fluency in English. Knowledge of other languages desirable 1. Experience in Pharmacovigilance/Drug Safety ac-tivities for more than 3 years 2. Ability to work independently and manage multiple tasks with prioritizing ability 3. Excellent verbal and written Communication skills 4. Good planning, organizing and interpersonal skills. 5. Excellent computer skills (proficiency in vendor management systems preferred)

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