Job Description

2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it\'s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role!

Are you ready to make a difference?

Job Summary/Purpose

In collaboration with the Director Patient Safety HUB, 3rd party vendors and local leadership, establish and drive pharmacovigilance strategy and operational excellence at country level, in compliance with the national and international regulations/standards/guidelines and corporate procedures, for all marketed and investigational products - drugs and medical devices - under the responsibility of all Sandoz companies and divisions. As Senior Manager Patient Safety in a large country with high regulatory demands and visibility, ensure the oversight of the quality management system for the PV system at local level, in collaboration with the Quality Assurance (QA) function. As a senior member in the country, influence local/global strategies to promote consistency and alignment between global and local PV-related processes and activities to meet local/global regulatory requirements. Supports the global/ regional talent development strategy by coaching and mentoring less experienced PS associates.

Your Key Responsibilities

Your responsibilities include, but not limited to

1. Leadership: In collaboration with the Director Patient Safety HUB and 3rd party vendors, provide key leadership skills based on expertise to the country to meet the strategic vision and regulatory requirements necessary in a large and/or complex country with high regulatory requirements. Key member in the country organization in demanding local organization that has high commercial and regulatory visibility. Key member of the local leadership team or influencing local leadership team to assure the country is meeting its regulatory obligations to the local health authority.

2. Single point of contact: As defined by local regulations act as the National Contact Person for Pharmacovigilance in the UK and act as the single point of contact with the Local Health Authority on a 24-hour basis concerning Pharmacovigilance vigilance matters.

3. Senior Manager Patient Safety: Act as the Senior Manager Patient Safety for all Sandoz divisions and group companies. Senior Manager Patient Safety may delegate the activities to a deputy, but the ultimate responsibility remains with the Senior Manager Patient Safety.
Delegation should be clearly documented. Act as local subject matter expert for local internal and external stakeholders in term of pharmacovigilance.

4. Management of Safety Information: Ensure oversight of the 3rd party Vendor and oversight of the structure and performance of Sandoz PV System at local level, to promote, maintain and improve compliance covering the following aspects:

• Local Procedures.
• Case Processing (triage/ documentation; translation; data-entry; follow-up activities and archive, as applicable).
• Expedite ICSR reporting and aggregate reporting (PSUR, DSUR, ASR) in relation to quality, accuracy, completeness, and timelines, as applicable.
• Cooperation and oversight of the implementation of local RMP commitments.
• Training of MAH personnel in relation to PV.
• Local Licensing agreements.
• Pre- and post-authorisation safety studies, with appropriate PS input as required.
• Patient Oriented Programs (POPs), Social Media Listening and Digital Engagement Assets Initiatives.

5. Documentation: Ensure access to all information sources maintained to oversee structure and performance of the PV system 3rd party vendor at local level.

6. Monitoring internal and external compliance of Safety Reports: Monitor internal compliance for local processing and external compliance (regulatory reporting) according to defined timelines. Ensure that delayed safety cases or aggregate reports are properly captured by 3rd party vendor, investigated and root causes addressed through any corresponding corrective/preventative action. Notification and escalation of any late case/submission to 3rd party vendor, QPPV, Director Patient Safety HUB.

7. Oversight of local PV third parties working on behalf of Sandoz: Monitor and assess the performance and productivity of PV 3rd parties in line with the applicable regulations, agreements, and standard operational/ working procedures in place. In collaboration with QA and Vendor Management functions, ensure corrective and/or preventive actions are implemented in case contractual commitments are not met, as applicable.

8. Regulatory Intelligence: Drive the impact assessment of new local pharmacovigilance-related legislation and provide strategic support to Global PS organization on local PV matters and impact of any changes at country and/or global levels.

9. Compliance with Local Legislation: Ensure the local Pharmaco-device vigilance requirements are met. Ensure Sandoz tools/systems configurations are in line with the specific local requirements to guarantee that the Country Organization receives all the safety information needed to meet local legislation (National Health Authority, Ethic Committees, etc.).

10. Health Authority Requests: In collaboration with 3rd party vendor, Regulatory Affairs (RA) and other functions, ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities in the region; ensure alignment with defined process and QPPV office in all safety-related responses, as applicable.

11. Audits and Inspections: In cooperation with the 3rd party vendor, QA applicable groups, manage any local Pharmaco-vigilance inspection and/or Pharmaco-device vigilance audit and proactively, cooperate in the implementation of any corrective/ preventative action as determined by auditors/ inspectors. Contribute as Pharmaco-device vigilance SME, in other internal Sandoz audits and/or third-party audits, as applicable.

12. EUQPPV-CPSH Network: As a senior member of EU-QPPV network, proactively contribute for the continuous monitoring and awareness of any emerging safety concerns at local level affecting the safety profile of the medicinal products for which Sandoz group of companies MAHs hold authorizations. Collaborate with RA, 3rd party vendor in the implementation of urgent regulatory actions at country level, as required.

13. Risk Management: Ensure the country oversight of implementation of additional Risk Minimization Measures at local level, in line with Sandoz procedures and applicable regulations/ standards/ guidelines.

14. Trainings: Ensure that all local internal and external stakeholders are adequately trained from pharmacovigilance obligations.

Minimum requirements

What you\'ll bring to the role:
- Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience
- Minimum 7 years\' experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
- Minimum 2-3 years of demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry
- Extensive knowledge of regional and local requirements relating to PV. Ability to solve complex regulatory issues and requirements.
- Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training. Proven ability to critically evaluate and integrate data from a broad range of areas/domains. Ability to effectively communicate with different stakeholders.
- Experience in PV audits and inspections.
- Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
- Experienced leader in a matrix organization, including ability to influence and provide guidance and direction to team members.
- Demonstrated ability for innovative and big picture thinking.
- Strong planning, negotiation, organizational and interpersonal skills.
- Computer/IT systems literacy
- Fluent in written and spoken English

Preferred Requirements:
- Knowledge of other languages

#Orbit

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we\'re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could achieve here at Sandoz!

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool

Functional Area

Research & Development

Division

SANDOZ

Business Unit

Global Finance SZ

Employment Type

Regular

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Novartis