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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 responsible for maintaining oversight and ensuring Local Operating Company (LOC) pharmacovigilance (PV) systems and processes in collaboration with appropriate functions and stakeholders.
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 and serves as a member of the EMEA Local Medical Safety (LMS) Leadership Team.
Key Responsibilities:
* Ensure local PV systems comply with regulations and company policies at all levels, including PV agreements with third parties.
* Implement and oversee PV and Risk Management systems to ensure proper oversight of products.
* Coordinate safety requirements as delegated by Marketing Authorization Holders (MAH) and report on compliance and risk indicators.
* Act as the nationally nominated person for Pharmacovigilance, collaborating with the QPPV office.
* Maintain PV audit and inspection readiness; serve as the contact for PV audits and inspections.
* Lead proactive benefit-risk management throughout the product lifecycle.
* Develop product knowledge focusing on safety profiles, Therapeutic Area (TA), and Disease Pathways to support medical and marketing teams.
* Identify operational efficiencies within the country/territory or function.
* Manage budget and resources effectively, collaborating with financial and functional leaders.
* Direct local safety activities to meet timelines and reporting requirements.
* Lead and mentor the safety team, fostering a culture aligned with LMS values.
* Participate in and lead projects at local, regional, or global levels.
Qualifications
Education: Degree or equivalent in life, health, or pharmaceutical sciences; proficiency in Medical terminology.
Experience and Skills:
Required: Experience in pharmaceutical regulations and R&D; minimum of 5+ years in pharma with at least 3 years in a pharmacovigilance role; proficiency in English.
Preferred: People leadership experience.
Other:
* Excellent communication skills, both verbal and written
* Ability to engage with internal and external stakeholders
* Strong relationship-building skills with health authorities and industry bodies
* 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 on employee wellness and career support, visit www.careers.jnj.com.
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