Specialist Consumer Safety Regions, APAC

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 Haleon's 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:

• Bachelor’s degree in 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

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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