RB is the world's leading consumer health and hygiene company, We work with the best people to challenge conventional thinking and keep giving people innovative solutions for healthier lives and happier homes, through our brands like Nurofen, Strepsils, Mucinex, Dettol, Lysol, Finish and Vanish.
A fantastic opportunity is available for a Global Vigilance Safety Report Writer to join our GVG (Global Vigilance Group) team.
Vigilance is essential to guarantee the ongoing understanding of the profile of adverse events related to the use of Reckitt Benckiser medicinal products, medical devices, cosmetics and vitamins, minerals and supplements (VMS).
This role is a crucial role since the post-holder is responsible for completing the key tasks in the provision of safety services and vigilance to facilitate and support the ongoing marketing of Reckitt Benckiser medicinal products, medical devices, cosmetics and vitamins, minerals and supplements (VMS).
RB: What makes us
What does it take to create healthier lives and happier homes?
Preparation, writing and management of vigilance safety reports (Periodic Benefit Risk Evaluation Report/Periodic Safety Update Reports (PBRERs/PSURs), Addendum to the Clinical Overview (ACO), Risk Management Plans (RMPs), Development Safety Update Report (DSURs)) and ad hoc safety reports for adverse events or supporting documents related to Reckitt Benckiser products.
Supporting local drug safety officers in operating countries for submission of safety reports and for the management of drug safety electronic records and databases relating to safety reports. Providing guidance and support for DSOs with guidance from the Team Leader.
Focusing on parts of the vigilance safety reporting process in direction from line management and the Director-Vigilance/EU QPPV of the Global Vigilance Group. Focus is allocated subject to business needs at the discretion of the Director-Vigilance/EU QPPV of the Global Vigilance Group.
Responsible for conducting any tasks to a high standard, accurately, timely with efficient completion as applicable, including ad hoc requests. To fulfil the requirements of the Knowledge Team and business needs at the discretion of the Team Leader, as per legislation requirements, Global SOPs and RB requirements.
Specific tasks and responsibilities include, but are not limited to:
Responsible for preparation, writing and management of vigilance safety reports or supporting documents from report request to report submission to Regulatory Authority.
Critical analysis of the safety data received for RB medicinal products for the benefit risk sections of PBRERs/PSURs and ACOs.
Characterisation of the safety profile of RB medicinal products and planning and implementing risk minimisation measures in RMPs.
Working with the Team Leader(s) to ensure all responsibilities regarding vigilance safety reports and other outputs and delivery are compliant with regulations, general quality standards, global standard operating procedures and Reckitt Benckiser values.
Ensuring that vigilance safety reports are of a high quality and quality checks are completed and in line with relevant industry requirements and according to SOP.
Completion of any request for further information and/or additional supporting document as per local requirements with direction from the Team Leader.
Ensuring that Drug Safety Officers in local operating countries receive training and support as appropriate for PSUR management
Work with the Team Leader and knowledge team members to ensure that the SOPs, templates, working documents and other appropriate documentation are updated and remain current in line with SOPs, industry regulations with direction from the Team Leader and senior management. Focus is allocated subject to business needs at the discretion of the Manager.
Training and support of new Knowledge Team members and retraining of existing Knowledge team member as required, with guidance from the Team Leader.
Meeting the compliance targets for monthly reports and management review. Completion of compliance metrics and appropriate documentation, as guided by the Team Leader.
Support the Team Leader in inspection/audit activities relating to information and support in preparation for the team to be inspection ready.
Do you have?
Minimum Bachelor’s Degree preferably healthcare or life sciences (or equivalent).
Experience writing Periodic Benefit Risk Evaluation Report/Periodic Safety Update Reports (PBRERs/PSURs), Addendum to the Clinical Overview (ACO), Risk Management Plans (RMPs), Development Safety Update Report (DSURs).
Experience in preparing medical or scientific documents to a high standard.
Experience in analysis of data and creation of summary reports or similar.
Excellent attention to detail, technical editing and QC skills.
Strong project management and organisational skills.
Experience with the use of databases.
Experience with the use of Microsoft packages.
Additional experience that may be beneficial:
Work experience in a global pharmacovigilance, medical device vigilance, cosmetics and vitamins, minerals and supplements (VMS) vigilance environment.
MedDRA coding experience and qualification.
Experience with Document Management systems.
Is this You?
Enjoys working with a variety of scientific, medical, safety and clinical data.
Able to interpret complex data and summarise accurately and succinctly.
An appreciation and understanding of global medicines regulations.
Ability to work across multiple reports and interact with various functions/departments.