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 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 perks-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