Scientist Pharmacovigilance Operations – Oversight and Strategy

The role ensures the safety of all Haleon (HLN) consumer, patient, and clinical trial participant users by supporting the collection, processing, and reporting of safety data globally. It oversees vendor activities, ensures quality and compliance of case processing, and drives continuous improvement of the global Safety Database.

Key Responsibilities

• Lead development, implementation, launch and maintenance of the global safety database with critical attention to program 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.
• Serve as point of contact for Consumer Safety Science and IQVIA on literature-specific queries.
• Support the Associate Director PV Ops Oversight and Strategy to ensure that processes are followed by third-party vendors, implementing quality and compliance oversight of 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, implementing quality and compliance oversight of 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 in context for the vendor model.
• Ensure 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).
• When process or training issues are identified, facilitate investigation into root cause, creation of corrective/preventive actions (CAPAs), and support remediation of process/training needs.
• Implement PV SCP training materials and curricula in line with current Consumer Safety Operations & Regions structure, and maintain 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.

Preferred Qualifications & Skills

• Bachelor’s 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 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 worldwide 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.

Benefits

• A competitive base salary
• Annual bonuses that reflect Haleon’s 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 company’s structure
• Childcare support
• Recognition programmes that reward incredible contributions
• Long-term incentives through share ownership (global grades)
• Hybrid@Haleon our philosophy to hybrid work – performance with choice

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. It’s important to us that Haleon is a place where all our employees feel they truly belong.

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. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.

Job Posting End Date: 2026-06-16