Johnson & Johnson Careers
PRODUCT VIGILANCE OFFICER
Requisition ID: 1805701691W
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
You will be providing support to the UK Product Vigilance department, including contributing to day vigilance activities for UK J&J Ltd products, and markets managed by the UK office.
Duties of the role:
• Understanding and following local UK SOPs and WIs, and relevant EMEA and GMS/OCMS procedural documents.
• Performing day-to-day case processing activities; receiving and acknowledging cases, maintain Safety report case files (RCF) including Adverse Event (AE) RCF, accurately enter AE information onto the J&J global database, handling administration of appropriate follow-up communications with consumers and healthcare professionals, QC of cases and ensure cases are closed according to relevant procedures.
• Providing safety information to Competent Authorities / Notified Bodies within required timelines.
• Verifying and monitoring daily, weekly and/or monthly reports from various sources.
• Assisting in Adverse Event and Product Quality Complaints (PQCs) Quality Check.
• Assisting in the quality check of Social Media Listening activities.
• Periodically reviewing local UK literature for AEs.
• You will be assisting in managing the Product Vigilance (PV) training of J&J colleagues and those working on behalf of the company and ensure timely completion of the training.
• Assisting with Presentations of PV training to colleagues.
• Accurate and timely documentation of deviations to process/timelines. Including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs)
• Supporting all occurrences of internal and external audits and inspections
Do you have the following Skills, experience and education we are looking for?
• Degree in Pharmacy or a Life Science ideal
• Proven expertise and experience in pharmaceutical regulations and processes is desirable
• Do you have a good working knowledge of Microsoft Office including Word, Excel, PowerPoint and Outlook?
• Capable of building and establishing strong and positive relationships
• Demonstrating exceptional attention to detail
• Excellent written and verbal communication skills
• Demonstrating the ability to work with teams and individuals
• Good presentation skills
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. We will consider all qualified applications for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Johnson & Johnson Limited (8700)