Scientist Pharmacovigilance Operations – Oversight and Strategy

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.

Scientist Pharmacovigilance Operations Oversight and Strategy

The position holder ensures the safety of all Haleon (HLN) consumer patients & clinical trial participants administered or using Haleon products by supporting the successful collection processing and reporting of safety data globally.

Specifically this role will be responsible for supporting vendor oversight to ensure quality and compliance along the case processing activities including literature cases from intake to submission of ICSRs globally. The job holder will work with a team of internal and external staff who will bring to life best in class model and KPIs for Pharmacovigilance single case processing to meet regulatory compliance worldwide. The job holder will support the global organization serving as a key contributor to provide oversight on vendor activities supporting vendor with clarifications identifying trends and risks as well as by ensuring compliance with regulations globally. The job holder should ensure vendor oversight of accountabilities thus driving compliance with standards and regulatory requirements. The position reports into the global Consumer Safety Global Operations (CSGO) Single Case Processing team (Associate Director PV Ops Oversight & strategy)

This position will ensure global case management activities align with HLN standards for processing of human safety information (HSI) and that regulatory requirements for case processing including quality compliance and on-time reporting to authorities and partners worldwide is achieved. This is done by driving dashboard and KPIs to meet the expected results from vendors on behalf of Haleon. The job holder is accountable for solving quality issues and support on Health Authorities related questions. A collaborative working relationship with suppliers and vendors to ensure regulatory requirements is expected to meet the KPIs.

The job holder will be required to leverage previous experience with vendor oversight and quality to make recommendations for the HLN SCP future state. The job holder provides relevant Pharmacovigilance operations excellence manages the Pharmacovigilance centralized vendor model team and drives the understanding training and implementation of case management requirements across all SCP vendors.

In this role you will

• Serve a Haleon PV Ops Single Case Processing global safety case processing SME leading the development implementation launch and maintenance of the global safety database with critical attention to the programs success while ensuring global case management activities align with HLN standards for PV processing.

• Support vendor oversight model to ensure third party implementation of PV SCP operative policies procedures trainings and relevant instructional materials for the global safety database worldwide users in compliance with regulations and industry standards to safeguard against inspection findings including but not limited to literature monitoring.

• Serve as point of contact for Consumer Safety Science and IQVIA on literature specific queries

• Support Associate Director PV Ops Oversight and Strategy to ensure that processes are followed by third party vendors by implementing quality and compliance oversight with case management PV processes and regulatory submission activities for HSI from all sources worldwide

• Act as point of Contact for ongoing queries or issues raised from global services provider(s)Central Safety legal QA and local operating companies concerning pregnancy cases new patient support programs reconciliations literature market research and license partner questions.

• Ensure that processes are followed by third party vendors by implementing quality and compliance oversight with case management PV processes and regulatory submission activities for HSI from all sources worldwide

• Support implementation of performance & process improvement initiatives and strive for simplification while keeping the complex regulatory environment into context for the vendor model.

• Support implementation of appropriate management monitoring plans are in place (Safety Management Plans Quality Management Plans Communication Plans) for vendor case processing safety information while meeting regulatory compliance with authorities and PV principles worldwide (including but not limited to CIOMS ICH GVP FDA EMA MHRA PMDA).

• Where process or training issues are identified facilitates investigation into root cause creation of corrective/preventative actions (CAPAs) and supports with remediation of process/training needs

• Implements PV SCP training materials and curriculums in line with current Consumer Safety Operations & Regions structure and maintains oversight of all CSOR training records and other aspects.

• Support Haleon during Health Authority interactions and inspections regarding PV Ops SCP aspects both written and verbal if required.

Why you

Preferred Qualifications & Skills

• Bachelors degree in a scientific or medically related field plus 3-5 years of experience in the pharmaceutical industry in pharmacovigilance regulatory affairs or other related industry discipline.

• Good knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements clinical safety documentation reporting of adverse events from clinical trials and spontaneous sources local regulatory requirements and pharmacovigilance methodology; understanding of world-wide pharmacovigilance regulatory requirements; other consumer health areas such as nutritionals cosmetics and devices a plus.

• Experience in pharmacovigilance/clinical safety or related experience

• Direct experience working with outsourced providers

• Experience with Literature monitoring in PV is desired

• Demonstrated project management skills in a global matrix environment

• Knowledge of principles of data collection manipulation and retrieval and experience summarizing data

• In-depth understanding of medical and drug terminology and coding (MedDRA IMDRF etc.)

• Ability to execute under tight timelines; solution-driven proactive way of working

• Proven experience of prioritization and time management

• In-depth knowledge of global PV case processing required

• Excellent communication skills

Opportunities for growth

None of us should ever feel like we are standing still. Instead we want Haleon to be a place where we feel like we are always progressing.

Improving everyday health takes dedication. Energy. Effort. So we look to reward your contribution with a benefits package that includes:

• A competitive base salary

• Annual bonuses that reflect Haleons performance

• Life insurance and pension plan

• Private medical package with additional preventive healthcare services for employees and their eligible dependents

• Health and wellbeing programmes that take care of you physically and mentally

• Pension plan membership and savings programmes

• Possibilities of development within the role and companys structure

• Childcare support

• Recognition programmes that reward incredible contributions

• Long term incentives through share ownership (global grades)

• our philosophy to hybrid work performance with choice

Job Posting End Date

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.

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.

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.