Associate, External Service Provider

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:

• No significant audit/inspection findings in area of responsibilities
  
• Active participation in ESP Governance meetings
  
• Contemporaneous management of Governance documentation in a manner that allows quick, accurate and complete retrieval of data for audit and inspection purposes.
  
• Timely escalation of ESP operational issues/ concerns to ESP Engagements team
  
• Timely support with ESP account management activities
  
• Internal and external customer satisfaction
  

Minimum Requirements: Work Experience:

• 1 to 2 years of Experience in Pharmacovigilance is preferrable
  

Skills: Excellent verbal and written Communication skills

• Good planning, organizing and interpersonal skills.
  
• Proficient in M.S. Office Suite (Word, Excel, PowerPoint) and Power BI
  
• ESP Engagements experience (preferable)
  
• Project management (preferable)
  

Languages:

• Fluent English (oral and written)
  

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?

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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.

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