Area Safety Lead UK, Ireland and Nordics
Kenvue – High Wycombe, England, United Kingdom
Kenvue Is Currently Recruiting For a Area Safety Lead UK, Ireland and Nordics
Location: Europe/Middle East/Africa, United Kingdom, England, High Wycombe
Work Location: Hybrid
Overview
The Area Safety Lead is responsible for ensuring that local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels, and in accordance with product vigilance agreements with third party partners. This role acts as the LOC’s main point of contact for pharmacovigilance matters with local health authorities and ensures appropriate product vigilance and risk management systems are in place for oversight of products within its responsibility.
What You Will Do
* Act as Local Nominated Person (including back-up nominated person) and function as nationally nominated person for Pharmacovigilance in respective countries as defined by national law. Collaborate with the QPPV offices as required.
* Provide oversight of the PV system and overall responsibilities; assist with vendor resources in scope; coach direct reports if applicable; delegate for the Area Safety Head when required.
* Record self-identified non-conformances, collaborate with the global team to investigate and develop effective CAPAs; support local information for European Economic Area/UK Pharmacovigilance System Master Files and local PSMFs as applicable.
Safety Management & Reporting
* Maintain up-to-date knowledge of local PV, cosmetic, and device vigilance requirements and reporting requirements; collaborate with the global team to implement changes for new requirements.
* Oversee day-to-day adverse event reporting inbound and outbound as applicable; respond to safety-related health authority queries in the territory.
* Ensure documented training on safety reporting responsibilities for LOC personnel and maintain awareness of safety reporting; oversee identification of local literature for AE reporting as required.
* Monitor regulatory impact on vigilance activities, reconcile with distributors, third parties, vendors, and internal stakeholders; notify local health authorities of safety issues (SSI/ESI and Signals) in collaboration with global and local teams.
* Ensure pharmacovigilance compliance of local company-sponsored programs and research activities; manage document control and archiving; provide information for local activities compliance; support risk management activities and KPIs.
* Perform translation for ICSR and PV-related documents as required.
Collaboration
Provide technical and strategic input and participate in projects/workstreams led by KMS teams or LOC.
Procedural Documentation
Maintain local procedures where applicable and assess impact of changes for alignment with global procedures.
Audit & Inspection Readiness
Support local health authority inspections and audits; respond to queries during inspections and collaborate with the global team to develop CAPA plans as applicable.
PV Contract Management
Manage PV clauses within local agreements.
Business Continuity
Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).
Qualifications
Minimum knowledge, skills, related experience and abilities for the position.
Education
Health care science professional (preferably Physician or Pharmacist).
Experience
* 4-6 years of relevant experience.
Knowledge, Skills, Abilities
* Pharmaceutical industry experience including product vigilance responsibility.
* Ability to organize workflow activities and manage multiple critical issues.
* Experience with vendor resource oversight.
* Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
* Expert knowledge of global, regional, and local procedural documents as applicable.
* Computer literate with knowledge of relevant IT safety systems.
* Excellent verbal and written communication skills; ability to establish and maintain open relationships within the organization and with authorities.
* Demonstrable knowledge of local requirements and global aspects of product safety.
* Fluency in the national language(s) and English.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Employment details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research
Industries: Personal Care Product Manufacturing
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