External Vigilance Engagement Manager
hace 7 días
**Summary**:
Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
**About the Role**:
The **External Vigilance Alliance Manager **provides expertise and advice on pharmacovigilance and / or device vigilance for all **_assigned _**Novartis Enterprise contractual arrangements including Global and Local Vigilance Agreements and Clinical Trial Supply Agreements. You will 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 Development, Patient Safety (PS) & Pharmacovigilance (PV) and external customers.
**Your key responsibilities, but not limited to;**
- 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.
- Take part in VAPRA activities for new deals as required to assess potential partner PV systems for the impact on Novartis Enterprise.
- 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 the Group Lead or senior EVAM**_._**:
- 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.
- With the Head External Vigilance Engagements / Group Lead communicate requirements to PS&PV functions and external line-units to ensure compliance with global vigilance agreements; with Head External Vigilance Engagements / Group Lead and Compliance Team, ensure external business partners and PS & PV 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.
- Supervise and control of local vigilance agreements, as required, to adhere to Development PS & PV standards.
- Support and advise PS & PV and concerned Novartis line-units on how to meet vigilance requirements for Clinical Trial Supply Agreements, including compliance monitoring as required.
- Initiate appropriate updates to vigilance agreement in a timely manner; support Head External Vigilance Engagements / Group Lead to ensure that vigilance agreements are implemented as required to maintain regulatory compliance and Development PS&PV standards. En
- sure accuracy and up-to-date information of agreements in the vigilance agreement repositories.
- Communicate data configuration requirements to Systems Operations to ensure accurate and complete automatic distribution of case reports to Vigilance Agreement Partners (VAPs) and regularly review and verify expediting requirements in collabo
- ration with the Compliance & Quality team.
- Assist in the development, maintenance and training Novartis PS & PV and other concerned departments on worldwide Novartis pharmacovigilance standards & procedures for pharmacovigilance agreements, using internal guidelines, tools and templates.
- Represent External Vigilance Alliance in internal and external meetings as needed, **_guided by senior Group Lead / senior EVAM as required_**.
- Support internal Novartis and VAP audits, Novartis audits of VAPs, VAP regulatory inspections, Novartis regulatory inspections.
**Desirable requirements**:
- Minimum 2 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 preferable.
- Strong negotiation/problem solving skills
- Experience and ability to work in matrix cross-functional environments.
- Organizational skills, planning, prioritizing and flexibility to adjust to changing deadlines and prioriti
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