Local Medical Safety Specialist, UK & Ireland, High Wycombe
Client:
Johnson and Johnson
Location:
High Wycombe, United Kingdom
Job Category:
-
EU work permit required:
Yes
Job Reference:
84f0dd344809
Job Views:
5
Posted:
24.04.2025
Expiry Date:
08.06.2025
Job Description:
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: Scientific/Technology
All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom
Job Description:
We are seeking a talented Local Medical Safety Specialist/Back-up Local Safety Officer for the UK & Ireland, based in High Wycombe, UK.
About Innovative Medicine: Our expertise in Innovative Medicine is driven by patient insights that fuel our science-based advancements. Join us to develop treatments, find cures, and pioneer from lab to life, championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine.
Purpose:
Local Medical Safety (LMS) ensures proactive Benefit-Risk Management throughout the product lifecycle by translating global safety data into insights and actions tailored to local needs. We support pharmacovigilance activities related to regulatory requirements for Marketing Authorization Holders (MAH) and study sponsors.
Responsibilities:
1. Back-up Local Safety Officer: Collaborate to ensure pharmacovigilance activities are handled satisfactorily, maintaining regulatory compliance at the Local Operating Company (LOC) level.
2. Benefit Risk Management: Develop product knowledge focusing on safety profiles, Therapeutic Area, and Disease Pathways to support local Medical and Marketing teams, and participate in safety signal detection and risk management planning.
3. Safety Regulations: Review and evaluate new safety regulations, assess impact on local processes, and implement changes accordingly.
4. Local Safety Compliance: Provide insights into safety metrics, own CAPA actions, and oversee procedural document review and improvements.
5. PV Contract Management: Review and manage pharmacovigilance agreements, oversee local safety unit training, and ensure compliance.
6. Local Communications: Coordinate safety-related communications with regional and global groups.
7. Aggregate Reports: Support the preparation of safety reports, review, and ensure timely submission to authorities.
8. PV Safety Training: Conduct training on pharmacovigilance and safety aspects for LOC employees, distributors, and vendors.
Qualifications/Requirements:
Essential Skills: Scientific or life sciences background, proficiency in medical terminology, ability to handle multiple issues, computer literacy, knowledge of industry principles, SOPs, and strong communication skills.
Experience: Pharmaceutical R&D and pharmacovigilance responsibilities, industry experience required.
Note: If you are not a passport holder of the country for the vacancy, a work permit may be necessary. Please do not include bank or payment details in your application. Apply via the 'Apply now' button.
#J-18808-Ljbffr