GSK looking for Senior Scientist Pharmacovigilance

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Post : Sr. Scientist Pharmacovigilance Operations Oversight and Strategy

About the role
• The Senior Scientist Pharmacovigilance Operations oversight & strategy 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, the Senior Scientist Pharmacovigilance Operations oversight & strategy will be responsible for supporting vendor oversight to ensure quality and compliance along the case processing activities, 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 Operations and Regions (CSOR) Single Case Processing director.
• 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 support that global case management activities are aligned with HLN 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. The job holder will strategically partner with PV Systems team to further develop the Haleon global safety database and business processes as needed.
• 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.

Role Responsibilities
• Serve a Haleon PV Ops, Single Case Processing global safety database SME leading the development, implementation, launch and maintenance of 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.
• Support vendor oversight model to ensure third party implementation of PV SCP Operations oversight & strategy 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.
• Deputize Associate Director PV Ops Oversight and Strategy as needed.
• 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.
• Be PV ops SME as designated on PV intelligence, safety automation and strategy efforts for SCP business contributions towards dashboards, design and implement Pv Ops Business insights and analytics, standard/ad-hoc retrievals for inspection purposes as well as various other automation and strategy initiative.
• Identifies and support implementation of performance & process improvement initiatives and strive for simplification while keeping the complex regulatory environment into context for the vendor model.
• Be the 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.
• Provides expert strategy, decision-making and oversight quality and compliance on ICSRs processes for SCP and in consultation with stakeholders as needed.
• 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).
• Support Haleon during Health Authority interactions and inspections regarding PV Ops SCP aspects, both written and verbal if required.
• 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.

Business Expertise & Problem Solving
• Compliance to regulatory requirements is essential to pharmacovigilance which is a highly regulated field worldwide. 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.
• 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 nutritionals, cosmetics and devices a plus.
• Compliance to global regulatory requirements is essential to pharmacovigilance which is a highly regulated field worldwide. 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.
• Third party vendor interaction, health authority inspections from all markets and License partners, support as business lead for development of new safety database.

Skills
• 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 nutritionals, cosmetics and devices a plus.
• Significant pharmacovigilance/clinical safety or related experience
• Direct experience working with outsourced providers.
• Demonstrated project management skills in a global matrix environment.
• Deep knowledge of principles of data collection, manipulation and retrieval
• 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.
• Demonstrates excellent communication skills.

Candidate Profile
• PharmD (Pharmacists degree)
• 10 to 14 years of experience working in the pharmaceutical industry.
• Experience in Pharmacovigilance and Medical Information regulatory requirements, systems, and processes
• Experience with medical governance across multiple geographies
• Doctor of Medicine (MD)
• Strong collaboration, planning, execution, and communication skills
• Ability to influence across a highly matrixed organization.

Additional Information
Experience : 5+
Qualification : PharmD (Pharmacists degree)
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance
End Date : 15th November 2026