02 ago
|
Sandoz
|
Baja California Sur
02 ago
Sandoz
Baja California Sur
As a newly listed, independent organization, we have an exciting, once-in-a-career opportunity to set our own path forward.
**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.
**KPIs**
Timely setting up of PVAs, implementation (e.g. Individual Case exchange, reconciliation)
**Role Requirements**
**What 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 of the 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.
- Experience and ability to work in matrix cross-functional environments.
- Cultural awareness and sensitivity; open and honest.
- Organizational skills, planning, prioritizing and flexibility to adjust to changing deadlines and priorities; ability to work independently and under pressure.
- Leadership skills for leading meetings, negotiations and implementation training.
What you will bring to the position:
You will receive: (not required) Breakdown of benefits received in this role. Also include adaptable work, learning and development opportunities.
Why Sandoz? 500 million patients received generic and biosimilar medicines from Sandoz in 2021, and while we are proud of that, we know we can do more to continue helping pioneer access to medicines for people around the world. How will we do it? this? We believe new insights, perspectives and innovative solutions can be found at the intersection of medical science and digital innovation. May a diverse, equitable and inclusive environment inspire new ways of working. We believe our potential can thrive and grow in a command-free culture underpinned by integrity, curiosity and flexibility. And we can reinvent what is possible when we boldly collaborate to aggressively and ambitiously address the world's most difficult medical challenges. Because the biggest risk in life is the risk of never trying! Imagine what you could achieve here at Sandoz!
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📌 Patient Safety Alliance Manager (Baja California Sur)
🏢 Sandoz
📍 Baja California Sur