AE Management Associate - 12 Month Secondment

City: Kingston upon Hull

We are Reckitt, home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

In Research and Development, we’re full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance. We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality. The size of our organisation means you’ll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

About the role:

Vigilance is essential to guarantee the ongoing understanding of the profile of adverse events related to the use of Reckitt’s medicinal products, medical devices, cosmetics and vitamins, minerals and supplements (VMS). This role is crucial 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 medicinal products, medical devices, cosmetics and VMS. The safety function is a statutory function imposed by external regulators.

Your responsibilities:

• AE Management - Associate is accountable overall to the AE Management - Manager, Global PV & Deputy QPPV & Director- Risk Management & Vigilance, European Union (EU) QPPV and Senior Vigilance Manager.
• Working with the AE Management - Manager and under the executive guidance from senior management to ensure all responsibilities regarding the processing (triage/entry/coding/evaluation/reporting/admin) of adverse event reports related to Reckitt’s medicinal products, medical devices, cosmetics and VMS is to a high standard, completed on time and according to regulations, domestic and foreign reporting requirements, general quality standards, Global Standard Operating Procedures and Reckitt values.
• Ensuring that all electronic records and paper records and the safety database are managed and maintained accordingly as per Standard Operating Procedure with specific actions taken from the AE Management – Manager.
• Ensuring that output from the group is of high quality and quality checks completed and in line with relevant industry requirements and Standard Operating Procedures.
• Ensuring AE Management team requests/queries and tasks, including ad hoc, are completed in a timely manner and according to industry requirements and Standard Operating Procedures.
• Ensuring the GVG mailbox is monitored and managed on a daily basis (business days).
• Ensure that DSO in local operating countries receive support as appropriate for the management for safety reports and database requirements.
• Work with the AE Management – Manager to ensure that the third-party case processors receive documentation as appropriate for case processing.
• Training and support of third-party case processors members with guidance from the Team Leader.
• Ensuring that all reports of adverse events related to Reckitt’s medicinal products, medical devices, cosmetics and VMS are processed in a timely fashion to ensure safety reports and PSURs are delivered to the appropriate regulatory authority on time and any ad hoc search requirements from the safety database can be delivered to the requester as required.
• Work with the AE Management - Manager to ensure that the SOP, working documents and other appropriate documentation are updated and current in line with standard operating procedures, industry regulations and direction from the Team Leader and senior management.

The experience we're looking for:

• RAS experience across product classifications with an understanding of appropriate pharmacovigilance legislation, including but not exclusively the Good Pharmacovigilance Practice (GVP).
• Good attention to detail; proven ability to quality check and analyse medical and scientific data including medical coding using regulatory dictionaries.
• Good communication skills and confidence in representing the function externally (audits/inspections with regulatory bodies), and internally (not limited to RAS); maintaining Reckitt’s legal obligations and embedding safety requirements and output in all that Reckitt does.

The skills for success:

• Business Strategy, Task Execution Under Pressure, Makes strategic Business Decisions, Business acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, Creative Direction, R&D, Change Leadership, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Relationship Management, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes, Digital transformation for R&D, Quality and Manufacturing.

What we offer:

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Equality:

We recognise that in real life, great people don’t always 'tick all the boxes'. That’s why we hire for potential as well as experience. Even if you don’t meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.