Senior PV Alliance Management Specialist

Welcome to Haleon. Were a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In 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. Hello. Were Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, were improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum through a unique combination of deep human understanding and trusted science. Whats more, were achieving it in a company that were in control of. In an environment that were co-creating. And a culture thats uniquely ours. Care to join us. It isnt a question. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, were uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. Its an opportunity to be part of something special. About the role As a Sr. PV Alliance Management Specialist, you will be responsible for ensuring local regulatory obligations for clinical safety reports are met. This includes the appropriate collection, processing and reporting of adverse events (AEs) for Haleon marketed and investigational products. Role Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following Review, extract, and accurately enter Adverse Event (AE) data from marketed product, reports received from spontaneous and solicited sources including health professionals, sales representatives, consumers and drug information in accordance with defined case handling procedures Review, extract, and accurately enter all serious AE information from clinical trial reports in accordance with defined case handling procedures Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete and accurate narrative summaries Ensure proper coding of Adverse Event terms and other medical terms into the global AE database. Process and prepare reportable cases within applicable timelines including accurate determination of expectedness using the relevant core safety information Review and comment on protocols/Case Report Forms (CRFs) for established and new products/programs and develops appropriate data entry protocol specific guidelines Remain current with case handling standards, guidance documents and database technology. Demonstrate in-depth working knowledge of regulatory environment & ensures compliance with safety data exchange agreements Work with departmental teams in maintaining and upgrading the safety database Why you We are looking for professionals with these required skills to achieve our goals: Experience with Good Clinical Practices (GCCP), clinical safety documentation and reporting of adverse events from clinical trials Experience with local regulatory requirements and pharmacovigilance methodology. Experience working with the principles of data collection, manipulation and retrieval Basic Qualifications: B.Pharma/M.Pharma/ PHD or M.Sc with relevant experience background Preferred Qualifications: 7+ years of Pharmacovigilance experience. Strong experience in SDEA (Safety Data Exchange Agreements) management. Experience in PV authoring/writing activities. Good understanding of PV Exposure and Safety Data Exchange processes. Experience in stakeholder/partner management within global PV operations. Location this role is based in Hyderabad Please save a copy of the job description, as this may be helpful to refer to once the advert closes. Diversity, Equity and Inclusion At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. Were striving to create a climate where we celebrate our diversity in all forms by treating each .