Risk Evidence Writer

The Risk Evidence Writer collaborates with relevant teams and functions and conducts standard scientific literature searches to produce evidence-based reports/position statements. These documents will be used by the business for product benefit-risk analyses and risk management activities, and for use in product safety defence, assessment and Competent Authority responses (e.g. PRAC, RFI and switch documentation).

The Risk Evidence Writer inputs into of all aspects of the Reckitt global signal management process, including signal surveillance for medicines, medical devices, cosmetics and other Reckitt products. The role will collaborate with multiple functions across the Global Safety Assurance group, and support various product development and maintenance projects regarding utilisation of adverse event/signal data for benefit-risk and safety risk minimisation activities/optimisation strategies.

As part of the Risk Management and Vigilance Team, the Risk Evidence Writer will be involved from product ideation/conception through to post-marketing safety review activities to help shape the safety risk minimisation activities, and input into safety messaging communications to limit and manage the risk of human harm to Reckitt consumers.

A minimum of 6 years in regulatory affairs, product safety or vigilance, crafting strategies and guiding teams through submission processes.

The Risk Evidence Writer has established scientific writing skills and can produce high quality, accurate and balanced documents to develop the guidance and company positioning for evidence-based benefit-risk strategies, and evidence synthesis activities for the benefit-risk safety assessments of Reckitt products. Additionally, the Risk Evidence Writer will drive the global signal management process implementation and signal data application for product safety core risk analysis, risk minimisation activity development and communication, as well as support signal detection systems deployment, maintenance, statistical data analysis protocols and training. The Risk Evidence Writer also collaborates with relevant functions and personnel on the research oversight of safety risk activities, as appropriate.

• Has demonstrable scientific writing and effective science communication skills.

• Supports literature search protocols and strategies by developing standardised scientific literature search strings (e.g. Emtree, MeSH).

• Conducts scientific literature searches and can critically appraise the output with preliminary synthesis of conclusions and safety position statements for internal and external use.

• Produces succinct and business accessible scientific evidence review reports.

• Supports the production of safety reports and position statements with benefit-risk and safety risk minimisation analysis input for general regulatory submissions (e.g. RMP, CCDS, request for information) and safety position generation across the RB product portfolio.

• Follows the overall signal management surveillance process and strategy across all Reckitt products (including medicines, medical devices, cosmetics and other products)

• Effectively communicates and escalates emerging safety signals as appropriate

• Inputs into the Regulatory and Safety processes for risk and core safety validation and communication.

Minimum bachelor's scientific degree essential and post-graduate qualification desirable.

 Relevant vigilance/pharmacovigilance or related product safety experience e.g. safety documentation authoring/review

 Experience across a broad range of therapeutic areas

 Previous experience of regulatory medical writing is essential

 Ability to critically appraise scientific data across multiple therapeutic areas

 Strong project management and organisational skills

 An appreciation and understanding of global medicines and medical device regulations