Vigilance Process Manager

Job Description

100+ process improvement initiatives in Operational Excellence! We are continuously improving pharmacovigilance processes and deliverables across Chief Medical Office and Patient Safety, ensuring adherence to Novartis Policies and compliance with international regulations, supporting the organizational strategy while striving for an enhanced productivity, quality and better patient outcomes.Your responsibilities include, but are not limited to: End to end management of assigned pharmacovigilance processes across Novartis Divisions; Responsible for ensuring compliance to global regulatory requirements with maximum efficiency Lead assigned cross functional patient safety projects -Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally Develop and maintain training material and communications for Novartis group and third party associates Support impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements Lead assigned process improvement initiatives including IT projects/systems (leading enhancements and managing releases). Analyze the impact of other process and organizational changes Work in collaboration with other functions to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements. In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions. Measure effectiveness of actions taken 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 corrective and preventative actions. Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant on regulatory requirements. Work jointly with other functions (like Compliance & Quality and Process Compliance & Risk Mitigation) to perform metrics trend analyses, generate knowledge and mitigate any identified risks. Mentor and train new starters Expertise in handling Pharmacovigilance processes in areas of Literature and Digital AE reporting and managing PV in data and digital preferred.Minimum requirements Leveraging digital technology / big data Strong negotiation and analytical skills Ability to work and lead (a cross-functional team) in a matrix environment Supporting audits & HA inspections Business Process Engineering Digital Medicine and Technology Pharmacovigilance Information & Knowledge Management Minimum 4 - 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance desirable. Experience in project management and demonstrated ability to lead work groups in a matrix environment. Experience of leading process improvement initiatives. 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. Ability to mentor and coach. Ability to work autonomously.WHY NOVARTIS769 million lives were touched by Novartis medicines in 2020, 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 whats 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!Commitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse team s representative of the patients and communities we serve.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: https://talentnetwork.novartis.com/network,

Keyskills :
managementcustomer servicedeliverycustomer relationsmisprocess improvement initiativesbig dataroot causemedical officepatient safetybusiness processanalytical skillstraining materialstatements of work sow