.Job Description SummaryResponsibility for Pharmacovigilance Agreements with external business partners, negotiations, implementation, compliance and maintenance.Job DescriptionAs a newly listed, independent organization, we have an exciting, once-in-a-career opportunity to set our own path forward.Together, we are shaping the future of Sandoz. Our momentum is driven by our talented and ambitious colleagues, who, in return for applying their skills, experience a supportive and collaborative culture, with impactful, flexible-hybrid careers, where diversity is welcomed, and personal growth is encouraged!Your Key Responsibilities:
- Maintain knowledge of current and developing regulations for pharmacovigilance and provide expertise and advice to all concerned Sandoz line units and external partners for Sandoz vigilance agreements, as required.
- Take part in due diligence activities for new deals as required to assess potential partner PV systems for the impact on Sandoz enterprise and take a leading role in developing the PV collaboration strategy with partners.
- Manage pharmacovigilance agreements with external business partners by leading and performing negotiations to define conditions of the agreement with external business partners, as well as ensure regular contact with key partners to facilitate agreement compliance and good relations.
- Communicate requirements to Patient Safety functions and other Sandoz line units to ensure compliance with vigilance agreements, as well as ensure external business partners and Patient Safety management and QPPV are alerted on compliance and reconciliation issues and have oversight of corrective actions to improve and maintain a high level of compliance.
- Perform timely review and updates of pharmacovigilance agreements and implementation, as well as accurate and up-to-date information of agreements in the vigilance agreement repository/ies.
- Closely interact with local and regional business functions on new or changing deals.
- Support inspection of Sandoz by Health Authorities, internal audits, Sandoz audits of Pharmacovigilance Agreement partners, partner inspections.KPIsTimely setting up of PVAs, implementation (e.G. Individual Case exchange, reconciliation).Role RequirementsWhat you'll bring to the role:
- Degree in Biomedical Science or related scientific discipline. Higher degree desirable.
- Fluency in spoken and written English, knowledge of other languages desirable but not mandatory.
- Minimum 4 years experience in pharmacovigilance or in a regulatory/compliance related area, of those at least 2 years working in Patient Safety Alliance; a thorough knowledge ofthe functional requirements of safety reporting, PV System and safety database, good knowledge of industry regulations and guidelines in the field of Pharmacovigilance.
- Strong interpersonal communication skills, strong negotiation and problem solving skills