Specialist Consumer Safety Regions, APAC

Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve grown evolved and are now entering an exciting new chapter one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now its time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose to deliver better everyday health with humanity at the heart of everything we do. It unites us inspires us and challenges us to be better every day driven by our agile performance-focused culture.

Position Purpose:

Responsible for the day-to-day management of consumer safety/pharmacovigilance operational activities for Haleon marketed products and products under development. This includes ensuring compliance with all local regulations and Company global pharmacovigilance cosmetovigilance device vigilance and nutrivigilance requirements whilst adhering to Haleons drive to ensure risk-based approach to fit for purpose safety processes.

This is a local PV role covering specific markets with strict regulatory requirements. The role is responsible for day-to-day local activities in line with required local vigilance regulations. This role is primarily responsible for Japan and supporting the regional assignments for other countries in APAC when needed.

Role Responsibilities

• Support Safety Regional Country Contact (SRCC)/Anseki role when required to ensure PV and consumer safety compliance in Japan.
• Supports Human Safety Information (HSI)/ Adverse event collection from consumers and all other sources related to Haleon Healthcare marketed products and investigational products in clinical trials in accordance with international and local regulatory requirements and guidelines.
• Coordinates the timely submission to local competent regulatory authority for safety/ vigilance documents.
• Maintains up to date local product list and contact list for countries in region.
• Supports local literature searches/ journal list review as appropriate.
• Supports appropriate Safety Vigilance training and GVP training to Haleon Japan employees and 3rd party staffs when needed.
• Supports Dear HealthCare Professional Letters (DHCPL) Dear Investigator Letter (DIL) submission to local HA if applicable.
• Provides expertise to support SRCC/local QPPV to ensure internal audit and HA PV inspection readiness.
• Supports regular GVP SOP update and implementation.
• Provides consultation and Human Safety Information/Safety clause for local contracts other than PVAs.
• Ensures Human Safety Information reporting compliance of Digital Market Research and Patient Support Program for local projects.
• Supports Internal PV audits and external local Regulatory Authority inspections as needed.
• Supports to ensure the Japan Singal case processing activities are completed in accordance with Haleon standard and regulatory requirements.
• Provides close monitoring of local regulations and product safety alerts for Haleon portfolio within the country and escalate identified safety concern/safety issue to SRCC timely.
• Supports the PV/Consumer safety activities in other countries within APAC region when applicable.
• Supports regional and global process Consumer Safety improvement initiatives for Haleon interacting with other key stakeholders as required.

Why you

Basic Qualifications:

• Bachelors degreein Healthcare or Pharmacy degree pharmaceutics or life/biological sciences is preferred
• Experience with Safety& PV Database and PV methodology
• Experience working with the principles of data collection manipulation and retrieval
• Experience in medical device vigilance activities is preferred.

Competencies and Skills:

• Experience in the field of Pharmacovigilance and drug safety as required
• Good understanding of Japan regulatory environment and Knowledge of Pharmacovigilance regulator and business requirements
• Understanding of diversity of Consumer Health businesses and local regulations for cosmetics medical devices and nutraceuticals
• Proven ability to influence and negotiate with key internal and external stakeholders
• Fluent oral and written English communication

Job Posting End Date

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture where different backgrounds and views are valued and respected all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. Its important to us that Haleon is a place where all our employees feel they truly belong.

During the application process we may ask you to share some personal information which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development refinement and execution of our inclusion and belonging programmes that are open to all Haleon employees.

The personal information you provide will be kept confidential used only for legitimate business purposes and will never be used in making any employment decisions including hiring decisions.

Adjustment or Accommodations Request

If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process please let your recruiter know by providing them with a description of specific adjustments you are requesting. Well provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@). If you are not sure whether the email you received is from Haleon please get in touch.