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Job ID297161BRPosition TitleSenior Pharmacovigilance Process Manager (80-100%*)Apply to Job
250! As Senior PV Process Manager, you will improve the daily work of 250 Novartis associates by ensuring a smooth and efficient process for preparation of aggregate reports. You will develop, monitor and optimize pharmacovigilance processes and associated metrics for preparation of aggregate reports to drive performance and quality, and ensure compliance with the worldwide regulatory requirements.
In this role, you will act as the functional lead and process owner for aggregate reporting processes (DSUR, PSUR, US Periodic Reports, or similar) within a diverse and globally distributed team of 6 – 7 process managers.
Your responsibilities will include:
• Lead the development and maintenance of procedural documents
• Drive continuous process optimization and simplification, develop training and communication strategies
• Ensure ongoing compliance to global regulatory requirements
• Establish clear processes for tracking regulatory compliance as well as compliance to internal requirements; work jointly with other Novartis functions to perform metrics trend analyses, generate knowledge and mitigate any identified risks.
• In case of incompliance to process or regulations, ensure investigation into the root cause and implementation of corrective and preventative actions is performed and the effectiveness of the actions measured.
• Support Pharmacovigilance Process Excellence management with developing and implementing objectives and group operational strategy
• Acting as subject matter expert during audits and inspections; lead the preparation of responses to findings and the development and implementation of CAPAs
What you’ll bring to the role:
• PharmD, MSc degree or equivalent in life sciences or related subject
• Fluency in English (written and oral)
• Minimum 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance and aggregate reporting (DSUR, PSUR, US Periodic Reports or similar)
• Proven organizational and project management skills with the ability to lead global and cross-functional working groups; dealing and interacting with a wide variety of people at all levels
• Strong negotiation and communication skills
• Experience of working with and supporting a team; ability to coach and mentor
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. 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.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.DivisionGlobal Drug DevelopmentBusiness UnitCMO & PATIENT SAFETY GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularShift WorkNo
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