Associate, External Service Provider (ESP) Engagements

Summary

Supports ESP Engagements team in supervision and oversight of pharmacovigilance activities outsourced to External Service Providers (ESPs).

Supports ESP Engagements team in ensuring appropriate governance of ESPs and support to communicate and implement ESP strategies.

About The Role

Major accountabilities :

• Support Associate Director ESP Engagements for the setup of new global ESPs.
• Support Associate Director ESP Engagements with contract setup & management.
• Support ESP account management including but not limited to GDDB account, Citrix account, maintenance of dashboard & data etc.
• Collaborate and support PS&PV QA in QMS implementation for outsourced activities.
• Support ESP Engagements team for the implementation of ESP governance and oversight of the outsourced activities.
• Support oversight of process improvement and innovation initiatives at ESPs.
• Act as Point of Contact (POC) for ESP IT issues.
• Supports ESP Engagements team to supervise compliance and quality of ESPs performing activities on behalf of Novartis. This includes facilitation and interaction with external and internal stakeholders to ensure contractual, internal, and regulatory expectations are consistently met.
• Contribute to effective transition and knowledge transfer of the assigned scope of services to the ESP through documentation, periodic performance reviews and alignment of the operational objectives between the two parties.
• Facilitate and manage interactions between both ESPs and Novartis functional teams including planning and logistics of periodic committees / meetings and performs follow-up on the actions originating from such meetings / routine interactions.
• Act as a liaison between ESPs and Novartis for exchange of ideas / proposals / target assignments to achieve highest efficiency, productivity, and compliance. Leverage the resources and expertise from both the organizations for the betterment of submissions / results and further continuous improvement.
• Support development of transition plans and offer guidance to other functional teams at Novartis to prepare project plans.
• Responsible for maintenance / update of ESP Governance documentation.
• Coordinate and support PS&PV and ESPs during business visits, audits and inspections for logistics, documentation, and CAPA development including closure of findings (if any).
• Track & alert ESP Engagements team of pending compliance issues, audit findings at ESP sites and propose preventative actions to avoid future findings.

Key Performance Indicators

Minimum Requirements

Work Experience :

Skills : Excellent verbal and written Communication skills

Languages

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Skills Required

Power Bi, Project Management