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Job Description:

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

This role is accountable to maintain oversight and ensure 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:

• 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 any PV agreements with third party business partners.
• Ensure to have an appropriate system of PV and Risk Management in place to assure appropriate oversight for products within its responsibility.
• Maintain overall responsibility for the coordination of safety requirements as delegated by Marketing Authorization Holders (MAH) and will report out on compliance and risk indicators to applicable MAH meetings.
• Act as nationally nominated person for Pharmacovigilance as defined by national law and collaborate with the QPPV office as required.
• Ensure PV audit/ inspection readiness at the LOC level at all times. Act as the local PV contact person for internal PV audits and external PV inspections.
• Ensure pro-active benefit-risk management throughout product life cycle.
• Demonstrate full product portfolio insight with local prioritization focus. Lead and support the LSU team to establish Product knowledge with focus on safety profiles, Therapeutic Area (TA) and Disease Pathway knowledge, supporting the needs of the local Medical and Marketing organization.
• Explore and implement operational efficiencies within the country/territory and/or within the function.
• Maintain budget control through effective resource management, insight in applicable financial cost center and collaborate with financial contacts and functional leaders where needed
• Direct local safety staff activities to ensure that specified timelines and reporting requirements are met.
• Lead and develop a team through mentoring and feedback.
• Be an ambassador of the LMS culture and vision!
• Participate and lead projects and initiatives locally, regionally or globally.

Qualifications

Education:

A degree or equivalent experience in life, health or pharmaceutical sciences is required, proficiency in Medical terminology.

Experience and Skills:

Required:

Experience in pharmaceutical regulations and R& D processes.

By preference a minimum of 5+ years pharmaceutical confirmed experience with at least 3 year in a product vigilance responsibility role.

Proficiency in English language.

Preferred:

People Leadership experience.

Other:

• Excellent verbal and written communication skills
• Ability to successfully engage with internal and external customers.
• Ability to establish and maintain open relationships within the organization and with health authorities and industry associations.
• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
• Excellent computer proficiency e.g MS Office,
• Proficiency in Global and Local Standard Operating Procedures (SOPs)
• Ability to work independently with minimum supervision.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.