Senior Safety Evaluation Scientist -III Literature Full-time

Pharmacovigilance Literature Assessment Position

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.

Perform Safety literature assessment activities for signal detection and aggregate reports purposes in accordance with their procedures and regulatory requirements. The position holder is responsible for the above elements in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV operations activities, including vendor oversight.

Responsibilities

• Screening and reviewing literature search results (articles/abstracts/citations) for purposes of aggregate report inclusion and potential safety signal identification
• Maintaining and documenting up-to-date product knowledge to aid in literature evaluation
• Support the SERM product specialists to run ad hoc searches to gather literature data.
• Ensure that discussions needed for, and priority of safety related findings/ signal reviews with the SERM product specialists / SERM physician, communications, escalations, and documentation of the outcome of signal detection process are done efficiently.
• Recognize potential issues and interact with team members to resolve issues
• Identify or participate in continuous process improvement activities related to area of responsibility or Template Doc ID: VQD-TEMPL-010209 Parent Doc ID: VQD-SOP-006022
• Maintain good documentation practice and be the Point of Contact in case of inspection/audit
• Maintain appropriate organizational networks

Basic Qualification

• Bachelor's degree in life sciences, pharmacy, medicine, nursing or a related health science.
• Minimum 7 years' experience in pharmacovigilance, drug safety, literature screening, medical affairs or clinical research.
• Pharmaceutical industry experience (e.g., drug safety (desired), regulatory, clinical development, medical affairs)
• Basic knowledge of post-marketing regulations applicable to drugs.
• Knowledge of the principles of causality assessment and the evaluation of safety signals.
• Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
• Working knowledge of key pharmacovigilance regulations and methodologies
• Basic knowledge of medical and drug terminology.
• Basic understanding of therapy areas of assigned products.
• Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation.
• Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
• Excellent English language skills – written and verbal particularly in scientific/medical terminology
• Ability to evaluate data and draw conclusions independently

We seek people who communicate clearly, act with integrity, and put patient safety first. We welcome different perspectives and create an environment of inclusion where everyone can bring their best. You will be supported to learn and develop your skills while making a meaningful contribution to global safety activities.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.