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Post : Pharmacovigilance Services Manager
Job Description
Creation and Implementation of Portfolio Quality Management framework for LS R & D engagement. Establish quality and compliance activities for existing and new scope of services. Lead and act as the point of contact for client audits and inspections by regulatory authorities Lead/contribute to the creation of formal processes; review and approve them as applicable. Assume overall document management responsibility for the assigned project. Ensure data security/privacy measures are implemented in deal teams, by the delivery leads and deal representatives. Lead Quality Governance meetings with clients where quality and compliance metrics are shared and discussed. Assign action items from these meetings to relevant SMEs and track them to completion. Ensure deviations and CAPAs are managed effectively and closed on time. Closely monitor and contribute to contract updates, subsequent changes required in the processes and monitor their completion. Focus on the standardization of processes and systems across all project locations. Lead the execution of all Audit/Inspection recommendations and findings in a timely manner and store objective evidence of completion of associated actions. Develop and lead the exection of deliverables in the Quality Management Plan for specific PV engagement in compliance with the contract for Accenture. Identify specific role-based training requirements and ensure the engagement team completes all deal and GxP related trainings in a timely manner. Provide periodic updates to clients (metrics delivery) and run the framework of continuous improvement. Monitor performance of team and resolve any conflicts that may arise within the team. Undertake additional responsibilities as and when required by the management.
Additional Information
Skill required : Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation : Pharmacovigilance Services Manager
Qualifications : MSc/Master of Pharmacy
Location : Bengaluru
Years of Experience : 13 to 18 years
End Date : 30th November 2024
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