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Location

Andhra Pradesh | India

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Job description

About the role

Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries into therapeutics for millions of patients. With the ever-evolving global regulations in the field of pharmacovigilance, with a focus on pragmatic approaches to protecting patient safety and incorporating the patient voice into the complex and evolving pharmacovigilance ecosystem. Forward-thinking safety case experts are invited to apply in Case Management Operations to facilitate effective application of new technologies and methods to streamline pharmacovigilance systems and processes to enhance protection of patient safety as products become more complex, new data sources drive new analytical techniques, regulatory requirements become more detailed, and medical product development becomes more global. As part of the Novartis Case Management Operations, this is an important role requiring your skills and application abilities to achieve operational excellence.

Your responsibilities include, but are not limited to:

• Monitor all case processing related activities to facilitate oversight on ESP’s quality and compliance of deliverables. Provide coaching and mentoring to all case processors including ESP's
• Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on accuracy, timeliness and quality
• Lead/support the process changes according to internal and externals drivers, including development and monitoring of process related metrics
• Support in audits/inspection as Subject Matter Expert, and develop and implement Corrective and preventative Actions (CAPA) to address safety findings
• Develop, contribute and maintain guidance documents including providing inputs to Vigilance Agreement (VA) and other such safety management plans
• Support in-collaboration with other functions within PS&PV to facilitate process improvements; Collaborate with Data Management team to enable reconciliation for locking of Clinical database. Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
• Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and databased, authoring or contributing to Product Specific Guidelines for assigned products. Lead the testing activities for case processing related safety systems/IT applications. Train and mentor new PS&PV associates
• Work with Novartis country safety departments, License partners and medical function to ensure that reports are accurately collected, evaluated and data based. Lead PS&PV Operational Projects or database validation activities as required

Role Requirements

• 3 to 5 years of experience in drug safety / Development or closely related areas of responsibility
• Good professional verbal and nonverbal communication skills
• Self-motivation and proactive stance to work
• Sense of urgency and commitment for timely completion of activities
• Previous Pharmacovigilance data entry experience is desirable.
• Strong negotiation and ability to operate effectively in an global environment and across line functions

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

Commitment to Diversity & Inclusion:

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

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Salary