28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
As a Patient Safety Alliance Group Lead, you will provide leadership and oversight within the Global Patient Safety Alliance team by acting as operational manager for a defined group of PS Alliance Managers.
You will also play a key role in assisting the Global Head of Patient Safety Alliances Operations to set the future strategy and direction of Global Patient Safety Alliance.Your responsibilities include:Expertise: Maintain knowledge of current and developing regulations/guidelines for pharmacovigilance and/or device vigilance and provide expertise and advice to all concerned Novartis line-units and external partners for Novartis Enterprise contractual arrangements, for co-development agreements and full marketing agreements, and including support for Clinical Trial Supply Agreements for individual trials and for local vigilance agreements for Novartis Group Companies, as required.Negotiation and Alliance Management: Manage assigned global vigilance agreements (within the defined PS Alliance sub-team) with external business partners by leading the negotiations to define conditions of the initial agreement, and the alliance partnership management thereafter.Regulatory Compliance: Communicate requirements to CMOPS functions and external line-units to ensure compliance with global vigilance agreements; ensure external business partners and CMOPS management are alerted to compliance and reconciliation issues and have oversight of corrective actions and their effectiveness to improve and maintain a high level of compliance.Local vigilance agreements: Supervision and control of local vigilance agreements, as required, to adhere to GDD CMOPS standards.Vigilance Agreements for Clinical Trial Supply Agreements: Support and advise CMOPS and concerned Novartis line-units on how to meet vigilance requirements for Clinical Trial Supply Agreements, including compliance monitoring as required.Maintenance: Ensure timely renewals and appropriate updates to vigilance agreements are implemented as required to maintain regulatory compliance and GDD CMOPS standards.
Ensure accuracy and up-to-date information of agreements in the vigilance agreement repository/ies.Database configuration: Communicate data configuration requirements to Systems Operations to ensure accurate and complete automatic distribution of case reports to Vigilance Agreement Partners (VAPs), and ensure that expediting requirements are regularly reviewed and verified in collaboration with the Compliance Quality team.Training and communication: Lead in the development, maintenance and training Novartis CMOPS and other concerned departments on worldwide Novartis pharmacovigilance standards procedures for pharmacovigilance agreements, using internal guidelines, tools and templates.Audits and Inspections: Supporting internal Novartis and VAP audits, Novartis audits of VAPs, VAP regulatory inspections, Novartis regulatory inspections.Commitment to Diversity Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements:Degree in Biomedical Science or related scientific discipline.
Higher degree desirable.English fluent - written and spoken, knowledge of other languages desirable but not required.Minimum 3 years experience in clinical safety/ (pharmaco)vigilance or in a regulatory/compliance related area including a thorough knowledge of the functional requirements of clinical safety reporting and a clinical safety database.
Good current knowledge of industry regulations and guidelines in the field of Pharmacovigilance and/or device vigilance.Experience in Clinical Trial Safety (including interactions with Clinical Teams, review of safety section of protocols, Safety Specifications Worksheets and Validation and Planning Documents, production of SAE workflows, completing safety database configuration requests, clinical trial case processing/evaluation) preferable.Strong interpersonal communication skills, strong negotiation/problem solving skills, strong leadership skills.Experience and ability to work in matrix cross-functional environments.Organizational skills, planning, prioritizing and flexibility to adjust to changing deadlines and priorities; ability to work independently and under pressure.Why consider Novartis?769 million.
That's how many lives our products touched in 2020.
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 individuals come together to make an impact.
#J-18808-Ljbffr
