- Entry level
- No Education
- Salary to negotiate
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 Negotiate - Manage assigned global vigilance agreements with external business partners by leading negotiations/negotiating team to define conditions of the agreement with external business partners, Alliance Management – ensure regular contact with key customers to facilitate agreement compliance and good relations, and acting as key contact person for external and internal stakeholders to identify needs and address resolution of issues. Regulatory Compliance – with PSAH communicate requirements to CMO&PS functions and external line-units to ensure compliance with global vigilance agreements; with PSAH and Alliance Compliance Member, ensure external business partners and CMO&PS management are alerted to compliance and reconciliation issues and corrective actions are developed 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 CMO&PS standards. Vigilance Agreements for Clinical Trial Supply Agreements - Support and advise CMO&PS and concerned Novartis line-units on how to meet vigilance requirements for Clinical Trial Supply Agreements, including compliance monitoring Maintenance - ensure timely renewals and appropriate updates to vigilance agreement are im-plemented as required to maintain regulatory compliance and GDD CMO&PS standards. Ensure accuracy and up-to-date information of agreements in the vigilance agreement repository/ies. Database configuration - communicate data configuration requirements to PVSDM to ensure ac-curate and complete automatic distribution of case reports to licensing parties and ensure that expediting requirements are regularly reviewed and verified in collaboration with Alliance Compli-ance Member. Training and communication – Assist in the development, maintenance and training Novartis CMO&PS Audits and Inspections: supporting internal audits, LP audits of Novartis, Novartis audits of LPs, partner inspections, Novartis inspections
Master Degree • Fluency in spoken and written English, 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 • Experience and ability to work in matrix cross-functional environments • Cultural awareness and sensitivity; open and honest. • Organisational skills, planning, prioritizing and flexibility to adjust to changing deadlines a
Division Global Drug Development
Business Unit CMO & PATIENT SAFETY GDD
Site Hyderabad, AP
Company/Legal Entity Nov Hltcr Shared Services Ind
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
About the company
Novartis has a clear mission, focused strategy and strong culture, all of which we expect will support the creation of value over the long term for our company, our shareholders and society. We recognize that our business depends on the creativity, dedication and performance of our associates. We encourage associates to focus on achievement through collaboration and innovation.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
Our company culture is guided by high ethical standards. Our values help guide the choices people make every day, and they define our culture and help us execute the Novartis strategy in line with our mission and vision.