| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
| Oil & Gas Jobs |
| Banking Jobs |
| Construction Jobs |
| Top Management Jobs |
| IT - Software Jobs |
| Medical Healthcare Jobs |
| Purchase / Logistics Jobs |
| Sales |
| Ajax Jobs |
| Designing Jobs |
| ASP .NET Jobs |
| Java Jobs |
| MySQL Jobs |
| Sap hr Jobs |
| Software Testing Jobs |
| Html Jobs |
| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Quality (QA-QC) |
| EmploymentType | Full-time |
Your responsibilities include, but are not limited to: Develop and implement quality and compliance metrics for new safety case management and aggregate reporting processes, working with the process/metrics owners, Quality Assurance (QA) and other global line functions as appropriate. Lead projects to optimize methodologies and processes used to monitor safety cases and aggregate reports quality as well as internal and regulatory compliance: Develop and maintain tools in collaboration with Innovation, Tech & Systems and other Global Line Functions to assist in the monitoring of quality and compliance, introducing automation where possible. Maintain procedural documents including manuals. Develop and implement training material and communications Assess the impact of any changes to worldwide regulations and/or Novartis group processes on existing metrics and update as required in order to ensure continued suitability. Review feedback from Health Authorities or other external parties and prepare responses and integrate the feedback in to Novartis group standards as appropriate. Manage assigned monitoring activities / metrics production: Lead investigations in to any deficiencies identified, develop and implement corrective and preventative actions (CAPAs) and measuring the effectiveness of these. Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of CAPAs. Collaborate with other Global Line Functions across Novartis Divisions, including Patient Safety Alliance, EU Qualified Person for Pharmacovigilance (QPPV), medical affairs and marketing to ensure implementation of CAPAs and fulfilment of the safety requirements. Escalation to CMO&PS leadership and other global line functions as appropriate and/or External Service Providers (ESPs) of compliance/quality issues. Represent CMO&PS externally as a subject matter expert on compliance and quality.Minimum requirements PharmD, MSc degree in life sciences or equivalent. Fluency in English. Knowledge of other languages desirable. Minimum 4 to 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance Experience in project management and demonstrated ability to lead working groups in a matrix environment Ability to deal and interact with a wide variety of people at all levels. Strong organizational skills Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions Strong analytical skills, Quality focus and ability to mentor and coachWhy consider Novartis 750 million. That s how many lives our products touch. And while we re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people s lives We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks, and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.,
Keyskills :
quality controlsafety case management life sciencesquality assurance service providerstraining material project management