Business Introduction:
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary:
You will lead safety case processing and support safety evaluation activities that keep patients safe. You will work with cross-functional teams across India and globally to ensure timely and accurate safety data handling. We value clear thinkers who act with integrity and care for patient outcomes. This role offers visible impact, strong learning opportunities, and the chance to grow within a global safety organisation that unites science, technology and talent to get ahead of disease together.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Expert in monitoring compliance by GSK and Third Parties with PVASC by carrying out routine HSI reconciliation, compliance checks and communicating standard information to Third Parties as required with appropriate guidance.
Expert in monitoring compliance with regulatory and internal quality of global adverse event reporting. This can include performing Quality Assurance assessments of adverse event reports entered in the GSK global safety database. Role will work independently on this task, identifying and escalating findings and issues as required.
Proficient in maintenance of information in the pharmacovigilance database, Electronic Data Management System (EDMS), PVASC website pages and shared areas including routine maintenance and documenting information as requested.
Expert in collection, evaluation, analysis, and documentation of information received from local operating company safety departments.
Expert in running standard listings from databases as required.
Expert to administer document storage and archiving including team site per the approved processes.
Represents during both external regulatory inspection and GSK audits of licensing partners with supervision from senior staff.
Provides inputs, to and maintain guidance documents and SOPs.
Can interact with colleagues in SERMs, Business Development, Operating Companies, and external companies as necessary with minimum supervision from senior staff.
Contributions/leads projects relating to improvements in processes and systems e.g., EDMS with supervisions from senior staff.
Performs other duties as assigned with supervisions from senior staff.
Basic Qualification:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals
Bachelor's degree in life sciences, pharmacy, medicine, nursing, or a related health science.
5 - 9 years of pharmacovigilance or drug safety experience, including ICSR processing.
Practical knowledge of pharmacovigilance regulations, Good Pharmacovigilance Practices, and clinical safety documentation.
Experience with safety databases and electronic case processing systems.
Strong medical terminology knowledge and experience with medical coding (e.g., MedDRA).
Excellent computer skills including Word, Excel, PowerPoint, and SharePoint.
Proficient in data visualization tools like PowerBI.
Proficient in incorporating AI/ML into everyday ways of working.
Ability to work independently with tight deadlines while under pressure; demonstrates planning and organizational skills.
Results driven with a sense of urgency that ensures timelines within personal control are met.
Good judgement, common sense, and pragmatism.
Functions as a team player.
Ability to work independently.
Able to build and maintain relationships outside of functional area.
Proactive problem identification.
Bridges personal, business, and cultural differences to work effectively in team settings.
Proficient in stakeholder management and customer focus.
What we value in you
We look for people who act with integrity, communicate clearly, and put patient safety first. We welcome different perspectives and foster inclusion. You will be supported to learn and develop while making a meaningful contribution to global safety activities.
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