Country Safety Head/ LSO, UK and Ireland

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function: Product Safety

Job Sub Function: Pharmacovigilance

Job Category: People Leader

All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

Job Description:

J&J IM is recruiting for a Country Safety Head/Local Safety Officer, located in the United Kingdom.

This role is accountable for maintaining oversight and ensuring Local Operating Company (LOC) pharmacovigilance (PV) systems and processes in collaboration with appropriate functions and customers.

The Country Safety Head (CSH)/LSO UK/Ireland is an employee of the Johnson & Johnson Innovative Medicine Office of the Chief Medical Officer (JJ IM OCMO).

This role leads and mentors the Local Safety Unit team.

Serves as a member of the EMEA Local Medical Safety (LMS) Leadership Team.

Key Responsibilities:

1. Ensure that the Local Pharmacovigilance system is run in compliance with local regulations and company policies/procedures at a local, regional, and global level, and in accordance with PV agreements with third-party partners.
2. Implement and oversee PV and Risk Management systems to ensure proper oversight of products within responsibility.
3. Coordinate safety requirements delegated by Marketing Authorization Holders (MAH) and report on compliance and risk indicators to MAH meetings.
4. Act as the nationally nominated person for Pharmacovigilance as defined by law and collaborate with the QPPV office.
5. Maintain PV audit/inspection readiness at the LOC level and serve as the contact for internal and external PV audits and inspections.
6. Ensure proactive benefit-risk management throughout the product lifecycle.
7. Demonstrate comprehensive product portfolio insight, focusing on safety profiles, Therapeutic Area (TA), and Disease Pathway knowledge, supporting local Medical and Marketing teams.
8. Explore operational efficiencies within the country/territory and within the function.
9. Manage budget and resources effectively, collaborating with financial and functional leaders.
10. Lead and develop the local safety team through mentoring and feedback.
11. Promote and embody the LMS culture and vision.
12. Participate and lead projects and initiatives at local, regional, or global levels.

Qualifications

Education: Degree or equivalent in life, health, or pharmaceutical sciences; proficiency in Medical terminology.

Experience and Skills:

• Minimum 5+ years in pharmaceutical R&D and regulations, with at least 3 years in a product vigilance role.
• Proficiency in English.
• People leadership experience preferred.
• Excellent communication skills, both verbal and written.
• Ability to engage effectively with internal and external stakeholders.
• Strong analytical skills to identify gaps and develop solutions.
• Proficiency in MS Office and knowledge of SOPs.
• Ability to work independently with minimal supervision.

For more information on how we support our employees\’ wellness, career, and life journey, please visit www.careers.jnj.com.

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