Job Summary

The Senior Scientist Pharmacovigilance Operations Oversight Strategy ensures the safety of all Haleon (HLN) consumer, patient, and clinical trial participants administered or using Haleon products, by supporting the successful collection, processing, and reporting of safety data globally.

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 workplace 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.

Interactions / Interpersonal Skills

- In-depth knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, clinical safety documentation, and the reporting of adverse events.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr. Scientist Pharmacovigilance Operations Oversight and Strategy (Hyderabad)
🏢 Haleon
📍 Hyderabad