Job Description

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:

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Support

Associate Director ESP Engagements

for the setup of new global ESPs.

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Support

Associate Director ESP Engagements

with contract setup & management.

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Support ESP account management including but not limited to GDDB account, Citrix account, maintenance of dashboard & data etc.

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Collaborate and support PS&PV QA in QMS implementation for outsourced activities.

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Support ESP Engagements team for the implementation of ESP governance and oversight of the outsourced activities.

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Support oversight of process improvement and innovation initiatives at ESPs.

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Act as Point of Contact (POC) for ESP IT issues.

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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.

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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.

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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.

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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.

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Support development of transition plans and offer guidance to other functional teams at Novartis to prepare project plans.

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Responsible for maintenance/update of ESP Governance documentation.

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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).

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Track & alert ESP Engagements team of pending compliance issues, audit findings at ESP sites and propose preventative actions to avoid future findings.

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Key performance indicators:

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No significant audit/inspection findings in area of responsibilities

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Active participation in ESP Governance meetings

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Contemporaneous management of Governance documentation in a manner that allows quick, accurate and complete retrieval of data for audit and inspection purposes.

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Timely escalation of ESP operational issues/ concerns to ESP Engagements team

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Timely support with ESP account management activities

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Internal and external customer satisfaction

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Minimum Requirements:

Work Experience:

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1 to 2 years of Experience in Pharmacovigilance is preferrable

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Skills:

Excellent verbal and written Communication skills

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Good planning, organizing and interpersonal skills.

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Proficient in M.S. Office Suite (Word, Excel, PowerPoint) and Power BI

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ESP Engagements experience (preferable)

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Project management (preferable)

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Languages:

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Fluent English (oral and written)

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Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards:

Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards



Division
Development
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.