Senior Patient Safety Manager

JR United Kingdom; Reading; On-site; GBP 70,000 - 100,000; Full time

Job summary

A leading company in sustainable biomaterials is seeking a National PV Contact Person to oversee pharmacovigilance activities. The role requires a professional qualification in Health Care Sciences and extensive experience in drug safety, offering a competitive salary and benefits in a collaborative environment.

Benefits

Competitive salary

Annual bonus

Pension scheme

Health insurance

24 days annual leave

Flexible working arrangements

Employee recognition scheme

Learning and development opportunities

Qualifications

• 10 years in drug safety or pharmacovigilance.
• 3 years of demonstrated leadership experience.
• Extensive knowledge of local pharmacovigilance laws.

Responsibilities

• Act as the National Contact Person for Pharmacovigilance.
• Lead pharmacovigilance activities within the local Affiliate.
• Ensure compliance with local pharmacovigilance requirements.

Skills

Leadership

Communication

Negotiation

Organizational skills

Regulatory knowledge

Education

Professional qualification in Health Care Sciences

Master's Degree or Equivalent

Job description

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Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Your Key Responsibilities:

Your responsibilities include, but not limited to:

UK National PV point of contact

• Act as the National Contact Person for Pharmacovigilance
• Collaborate and work with the UK-QPPV

Leadership and Influence:

• Lead and oversee pharmacovigilance activities within the local Affiliate.
• Advocate for local Affiliate’s needs at local, regional, and global levels.
• Promote a comprehensive understanding of the PV system within the organization.
• Ensure adherence to local safety requirements.
• Represent the local Affiliate(s) in cross-functional and global-regional-local frameworks.
• Drive the integration of safety procedures within the organization.
• Establish strong partnership with the local Affiliate leadership and ensure exchange of key pharmacovigilance topics
• Externally influence the local regulatory environment by participating in key local pharmacovigilance associations
• Line management accountability and operational leadership of affiliate Patient Safety Staff

Information Flow and Collaboration:

• Facilitate efficient exchange of safety-related information within the Affiliate and within the PS organization (UK-QPPV, Patient Safety Regional Lead).
• Collaborate with the following but not limited to local business partners, Patient Safety regional leads, QPPV, and third-party vendors.

Safety Expertise and Support:

• Stay informed about Sandoz product safety profiles.
• Support launches of Sandoz products in the territory by providing pharmacovigilance expertise during all phases of product development.
• Communicate with the local Health Authority as appropriate
• Provide safety expertise for marketed and investigational products.
• Support risk management plans and additional risk minimization measures (aRMMs) implementation.

Oversight:

• Develop, implement and maintain oversight mechanisms for safety related activities conducted in the Affiliate and keep the compliance.
• Ensure compliance with local pharmacovigilance laws and quality standards.

Quality Management System:

• Contribute to the local quality management system.
• Contribute to maintenance of the local UK PSMF (PV System Master File)
• Engage in training, records management, and regulatory intelligence.
• Ensure audit and inspection readiness.
• Host and lead local inspections and audits

What you’ll bring to the role:

• Professional qualification in Health Care Sciences (e.g., Medical Doctor, Pharmacist, Nurse)/ Master's Degree or Equivalent
• Minimum 10 years in drug safety or pharmacovigilance with 3 years of demonstrated leadership.
• Excellent communication skills in English. Knowledge of other languages is desirable
• Extensive understanding of local pharmacovigilance requirements, with the ability to address complex regulatory issues.
• Proficient in pharmacovigilance processes, including compliance, databases, procedures, quality assurance, and training.
• Proven ability to critically evaluate and integrate data from diverse areas/domains.
• Effective communication skills with various stakeholders.
• Experience in pharmacovigilance audits and inspections.
• Demonstrated ability for innovative and strategic thinking.
• Strong planning, negotiation, organizational, and interpersonal skills.
• Proficiency in computer and IT systems.

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Commitment to Diversity & Inclusion:

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

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: Sandoz Talentpool (novartis.com)