Provide expertise and advice on pharmacovigilance and/or device vigilance for all assigned Novar-tis Enterprise contractual arrangements including Global and Local Vigilance Agreements, Clini-cal Trial Supply Agreements and Patient Safety. Negotiate and maintain global vigilance agreements with external business partners, managing these global alliances, including oversight of compliance, and acting as key contact person for GDD, CMO&PS and external customers.
1.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.
2.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, guided by senior PSAM / PSAH as required.
3.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.
4.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.
5.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 as required.
6.Maintenance - ensure timely renewals and appropriate updates to vigilance agreement are im-plemented as required to maintain regulatory compliance and GDD CMO&PS standards. En-sure accuracy and up-to-date information of agreements in the vigilance agreement reposito-ry/ies.
7.Database configuration - communicate data configuration requirements to PVSDM to ensure accurate and complete automatic distribution of case reports to licensing parties and ensure that expediting requirements are regularly reviewed and verified in collaboration with Alliance Compliance Member.
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Degree in Biomedical Science or related scientific discipline. Higher degree desirable. English
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 Patient 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
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