Senior Scientist Pharmacovigilance Single Case Processing, Standards

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve 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 it’s 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.

Senior Scientist Pharmacovigilance Single Case Processing, Standards

About the role

The Senior Scientist Pharmacovigilance Single Case Processing, Standards ensures the safety of all Haleon consumers, patients & clinical trial participants administered or using Haleon products, by supporting the successful collection, processing and reporting of safety data globally.

The Senior Scientist PV SCP Standards will be responsible for implementing the appropriate Pharmacovigilance single case processing standards in order to meet regulatory compliance worldwide.

This role safeguards PV SCP standards and knowledge management, while ensuring global case management activities align with Haleon standards for processing of human safety information (HSI) and that regulatory requirements for case processing, including quality, on-time reporting to authorities and partners worldwide is achieved. This is done by delivering the implementation of robust operative processes and training for successful performance of central to local case management activities, including PV vendor oversight mechanisms.

In this role the person will support the global safety database development serving as a key workstream contributor delivering a new Pharmacovigilance case inclusive of case prioritization workflows, processes, policies and launch of the new system under critical, demanding timelines.

The position reports into the Consumer Safety Global Operations (CSGO) Single Case Processing team.

In this role you will…

• Serve a Haleon PV Ops, Single Case Processing global safety database SME in the maintenance and support for upcoming releases involving the global safety database with critical attention to the program's success, while ensuring global case management activities align with HLN standards for PV processing.
• Generate PV Ops, SCP operative policies, procedures, trainings and relevant instructional materials for the global safety database worldwide users in compliance with worldwide regulations and industry standards to safeguard against inspection findings.
• Serve as point of contact for Consumer Safety and IQVIA on case processing specific queries.
• Support Haleon during Health Authority interactions and inspections regarding PV SCP aspects, both written and verbal, if required.
• Support the development and continuous improvement of the global safety database as workstream content contributor and support backlog grooming sessions, iterative review of requirements (user stories, data requirements, mappings and other decisions relevant to PV SCP.
• Assess training delivery needs and develop training storyboards that will be created and uploaded to the learning management system by Quality and Document Control (QDC).
• Identify target training audiences applicable to procedural documents and mapped to training curriculum.
• Create processes that ensures quality and compliant oversight with case management PV processes and regulatory submission activities for HSI from all sources worldwide in order to meet regulatory compliance with authorities and PV standards, including but not limited to CIOMS, ICH, GVP, FDA, EMA, MHRA, PMDA.
• Maintain PV SCP training materials and curriculums in line with current CSGO structure and oversight of all SCP training records and other aspects.
• Lead cross-functional training of relevant stakeholders.

• Participate in special projects as assigned.

Why you?

Basic qualifications

• Min. BSc degree in a scientific or medically related fields such as Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Toxicology, Medical Engineering).
• Applied level with experience (min. 5 years) in the pharmaceutical industry/Consumer health in pharmacovigilance, regulatory affairs, clinical safety or other related industry discipline.
• Ability to effectively communicate and negotiate in relation to technical regulatory application of laws, standards while applying drawn industry experience to critical decision making for product assets worldwide.
• Knowledge of principles of data collection, manipulation and retrieval and experience summarizing data.
• Direct experience working with outsourced providers.
• In-depth 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 nutritional's, cosmetics and devices a plus.
• Demonstrated project management skills and prioritize competing priorities.
• 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, prioritization and time management.
• In-depth knowledge of safety databases required.
• Proactive, independent, solution driven approach, ability to manage complexity.
• Excellent communication skills.

Preferred Skills:

• PHD degree nice to have.
• Knowledge of Veeva Safety Vault database.

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:

• Career at one of the leading global consumer companies.
• Hybrid work.
• Reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement).
• Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities) .
• Private medical care - the cost of the basic package is financed by Haleon. In addition, candidates can extend the selected package to family members and/or partner and purchase also the Senior package.
• P4P Partnership for Prevention.
• Family benefits (extra parental leave, caregiver’s policy).
• Life insurance and pension plan.
• Multisport card or points on the Multicafeteria Benefits account.
• Personalized learning approach.
• Supportive community and integration events.
• Modern office with creative rooms.
• Free car and bike parking.

Location - this role is based in: Warsaw, Poland

This position is a grade: 7

Please save a copy of the job description, as this may be helpful to refer to once the advert closes.

PLN 213 542,00 - PLN 293 619,70 The salary range for this position is indicative and provided as a guide. The final offer may vary depending on factors including relevant experience, skills, qualifications, and internal equity considerations. Further details regarding the total reward and benefits package will be shared during the recruitment process. Salary ranges may vary by location in line with local market conditions and applicable pay transparency regulations. Compensation information is shared for the primary location of this role. Where the position is advertised with additional locations the compensation range will be discussed during the recruiting process.

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. It’s 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. We’ll 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 (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.